Trial Manager Resume Sample
Gustave Crona
33049 Quinton Squares,
Philadelphia,
PA
+1 (555) 153 0090
Work Experience
Trial Manager
08/2015
-
PRESENT
New York, NY
- Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trials and activation of clinical trial sites
- Accountable for the operational oversight of assigned IISs at an operating company level from start-up (post ReCAP approval) through receipt of the final deliverable and close-out activities and that IISs are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
- Accountable for the operational oversight of assigned collaborative studies at an operating company level from start-up (post ReCAPapproval) through receipt of the final deliverable and close-out activities and that collaborative studies are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
- Excellent communication, negotiation, networking and interpersonal skills. Proficient in speaking and writing the country language and English. Proven track record in contract negotiation and problem resolution.1700180602W
- Excellent communication, negotiation, networking and interpersonal skills. Proficient in speaking and writing the country language and English. Proven track record in contract negotiation and problem resolution
- External Interfaces: Trial Site Personnel, external vendor representatives
- Understanding of the drug development process including GCP and local regulatory requirements is required
- Flexible mindset and ability to work in a fast-changing environment
Local Trial Manager
08/2010
-
03/2015
Chicago, IL
- Solid understanding of the drug development process including GCP and local regulatory requirements is required
- Solid leadership skills required
- Proficient in speaking and writing the country language and English language required
- Flexible mindset and ability to work in a fast-changing environment required
- Minimal business travel (meetings, training, etc.) required
- Fluent in English (oral and written); French is an advantage
- Clinical research experience in Oncology is required
- Solid understanding of the drug development process including ICH/GCP and local regulatory requirements is required
- Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment is required
Senior Local Trial Manager
10/2007
-
02/2010
Chicago, IL
- Work on multiple trials in parallel in different disease areas is required
- Strong computer skills in appropriate software and related company clinical systems is required
- Proficient in speaking and writing the country language and English is required
- Strong written and oral communication is required
- Willingness and flexibility to travel is required. with occasional/regular overnight stay
- Willingness and flexibility to travel is required with occasional overnight stay
- Project planning, initiation, execution, change control, and closing.
- Project team development, project team leadership, meeting management, and resource coordination.
- Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.
Education
Adventist University of Health Sciences
2002 - 2007
Bachelor's Degree in Health Sciences
Professional Skills
- Excellent communication, networking, coordination and influencing skills
- Effective leadership- and influencing skills and ability to build strong and trustful partnerships both internally and externally
- Excellent decision-making skills and ability to think out of the box
- Good problem solving skills, ability to coordinate and prioritize
- Proficient in speaking and writing the country language and English language. Good written and oral communication skills
- Demonstrates an excellent understanding of the clinical study , drug development , sample
- Fluent written and verbal communication skills in Danish including a good command of English language
How to write Trial Manager Resume
Trial Manager role is responsible for clinical, manager, eligibility, pharmaceutical, leadership, software, computer, speaking, english, research.
To write great resume for trial manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Trial Manager Resume
The section contact information is important in your trial manager resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Trial Manager Resume
The section work experience is an essential part of your trial manager resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous trial manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular trial manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Trial Manager resume experience can include:
- Good analytical skills and solution oriented, actively seeking input from others is required
- Strong computer skills in appropriate software and related clinical systems is required
- Prior experience with cardiovascular and/or metabolics Therapeutic Areas required
- Clinical operations knowledge, project management and proficient communication skills are required. Computer literacy is also required
- Understanding/practical experience with in vivo pharmacology and/or bioanalysis
- Previous line management experience (incl. performance management, coaching and development planning)
Education on a Trial Manager Resume
Make sure to make education a priority on your trial manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your trial manager experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Trial Manager Resume
When listing skills on your trial manager resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical trial manager skills:
- Strong communication and interpersonal skills, and excellent customer service skills
- Strong IT skills in appropriate software and company systems
- Very good communication and computer skills required
- Strong organization and management skills.
- Experience in monitoring of clinical trials or at least 1-year experience in project management acquired in pharma company or CRO
- Demonstrated strong understanding of company's systems and processes
List of Typical Experience For a Trial Manager Resume
1
Experience For Local Trial Manager Resume
- Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to
- Actively contributes to process improvement, training and mentoring of CTAs, SM and other LTMs
- Conducts local trial team meetings and provides or facilitates SM training when needed (i.e
- Management of customer / stakeholder expectations; facilitation of cross-functional decisions.
- Prepares master informed consent and country specific informed consent(s) in accordance with GCO procedural document/templates. Reviews and manages site specific informed consent forms in accordance with GCO SOPs, WIs and applicable regulations
2
Experience For Global Trial Manager Resume
- Ensures that relevant local insurances are obtained and maintained, where applicable
- Acts as a local expert for regulatory affairs and/or ensures availability in each country of a local expert for regulatory affairs to ensure that the trial is in compliance with local regulatory requirements
- Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list.
- Develop networks within and across the centre to ensure the success of the team’s objectives and long term plans
- Make recommendations for developments of established processes and procedures
3
Experience For Senior Local Trial Manager Resume
- Ensure that work is undertaken and documented in a regulatory compliant way and be prepared for regular audits and inspections, as well as contributing to the development of the quality management system for the area of trial management
- Efficient, quality-driven, timely execution of global clinical trials in compliance with international and local regulations and Novartis internal standards
- Timely and delivery of high quality clinical trial documents to achieve critical milestones
- Accountable for the operational oversight of assigned IISs at an operating company level from start-up through receipt of the final deliverable and close-out activities and that IISs are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
- Accountable for budget oversight for assigned IISs including forecasting and ensuring if applicable vendors and affiliate budgets are delivered according to plan
- Communicates budget discrepancies or payment delays with rationale to Operating Company Representatives and Clinical Program Leader
- For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the Clinical Program Leader Study Responsible Physician/Study Responsible Scientist
- Proactive operational planning with effective contingency and risk mitigation plans
4
Experience For Senior Global Trial Manager Resume
- Contribute to talent development through active participation in OnBoarding and training activities
- Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management
- Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards
- Collaborate with the Clinical Practice Leader (CPL), GTL, country TMs (if applicable), functional management and Protocol Owner to select final site list
- Maintain and update trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and SharePoint sites)
- Monitor country and overall study progress (if applicable) and initiate Corrective and Preventive Actions (CAPAs) when the trial deviates from plans and communicates study progress and issues to CPL, GTL, protocol owner and study management teams. Ensure appropriate documentation and follow-up related to protocol issue escalation
- Lead and coordinate negotiation of trial site contracts and budgets as needed
5
Experience For Ex Global Trial Manager Resume
- Review and approve Monitoring Visit Reports submitted by SM, which identifies issues and/or trends across a trial project and escalates deviation issues to the GTL and Functional Manager (FM) as needed
- Act as primary local or multi-country contact in GCO for a trial. Establish and maintain excellent working relationships with external stakeholders, such as investigators, trial coordinators, other site staff, key contacts in ED&CP and other internal stakeholders
- Actively contribute to process improvement initiatives, and training and mentoring of SMs, Clinical Trial Assistants (CTAs) and other TMs
- Supporting management of interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations
- 2 Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes. Extended member of the Global Clinical Team (GCT)
- Participate in data review as specified in the Data Review Plan
- Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s) and within clinical program(s) and franchise
- Accountable for the operational oversight of assigned IISs at an operating company level from start-up (post Re CAP approval) through receipt of the final deliverable and close-out activities and that IISs are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
- Accountable for budget oversight for assigned IISs including forecasting. Communicates budget discrepancies or payment delays with rationale to Operating Company representatives and Clinical Program Leader
6
Experience For Global Trial Manager Pre-approval Access Resume
- For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the Clinical Program Leader and Study Responsible Physician/Study Responsible Scientist
- Establishes and maintains excellent working relationships with external working relationships with external organizations, in particular investigators, study trial coordinators and other site staff, internal partners, including Medical Affairs and R&D Therapeutic Areas
- Effective leadership skills and attested ability to further team productivity and cohesiveness is required
- Stays in sync with relevant training requirements
- Actively participate and commit to the productivity and cohesiveness of the team is required
- The ability to work on multiple trials required
- Leads the SMT as the single point of accountability for end-to-end project management including high level budget estimate, protocol development, trial set-up, execution, close-out, analysis and reporting
- Prepares or contributes to high level budget estimate in response to Request for Services followed by detailed budget proposal
- Provides regular status updates to SMT, project owners and Clinical Team members. Ensures required reports are generated and available for real time tracking of project status
7
Experience For Senior Trial Manager Resume
- In coordination with the Functional Manager/CPL, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, the TM provides adequate project-specific training to the GCO or CRO teams and to the site staff. Works with GCO/CRO staff in the set-up and coordination of Investigator Meetings, if applicable
- Identifies and proactively manages issues in a timely manner
- Communicates regularly with the Functional Manager/CPL/COH
- Escalates issues and manages risks related to resources, timelines and budgets
- Build proposal for Action Plan(s) with the SMT to implement solutions on a project level
- Internal contacts:Functional Manager, CPLs, COHs, GTMs, GTM-CTAs, GCDO functions, GCO Country teams, Country Medical Affairs teams, SMTs, , Legal, Finance, QS, PDMS, Regulatory Affairs, Quality Management & Training group, Quality Assurance group, Procurement (JRP), Project Owners and other J&J enterprise sectors, as applicable
- External contacts: external service providers, clinical investigative sites and their research staff
8
Experience For Expert Global Trial Manager Resume
- Primary point of contact to pick-up and manage ad-hoc requests, oversees implementation and keeps oversight of managed access activities in the TAs. Translates ad-hoc solutions into lessons learned for team members and other functions
- Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of
- Pre-trial visit report and country feasibility report. Recommends suitable sites for selection to
- Contributes input to the study management documents at a country level or initiates development of
- These documents for a single country trial, as per SOPs
- Manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines
- Implementation of study amendment-and changes in study related processes)
- Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list
9
Experience For Local Trial Manager M/F Resume
- Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations
- Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements
- Collaborate with FM/CRM for country protocol feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL. Implements any local criteria for site selection
- Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial
- Collaborates with the Global Project Lead (GPL), Clinical Trial Manager (CTM)/Global Trial Lead (GTL), local management/Country Head and other study team member to select final site list
- Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate
- Maintains and updates trial management systems. Uses study tools and management reports available to analyze trial progress
10
Experience For Dsm Trial Manager Resume
- Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams
- Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed
- Reviews and approves site and local vendor invoices as required. Manages local study supply, as required
- Prepares country specific informed consent in accordance with GCO procedural document/templates
- Reviews and manages site specific informed consent forms in accordance with GCO SOPs, other procedural documents and applicable regulations
- Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is compliant with local regulatory requirements
- Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
List of Typical Skills For a Trial Manager Resume
1
Skills For Local Trial Manager Resume
- Demonstrated proficiency in the monitoring and management of clinical trials (preferably with LTM experience)
- Clinical operations knowledge, project management and proficient communication skills are required
- Proven track records of good performance
- Experience/exposure working with outsourced and/or collaborative studies including data transfer to sponsor activities
- At least three years of clinical research experience in on-site monitoring and project management
- Work under limited direction and to establish and maintain effective working relationships with coworkers, managers and clients
2
Skills For Global Trial Manager Resume
- Experience with CNS in vivo work, including independent project execution and preferably project supervision
- Acts as primary local/country contact for a trial. Establishes and maintains excellent working
- Basic knowledge of Good Clinical Practice
- Experience in project management acquired in pharma company or CRO
- At least 3‐4 yrs pharma company or CRO clinical research experiences
- Preferably Hands‐on experiences of related Therapeutic areas
- Excellent communication, interpersonal, positive attitude and teamwork abilities
- Evidence of ability to explore investigators’ needs and adapt the team accordingly to ensure a quality study is delivered
3
Skills For Senior Local Trial Manager Resume
- Full life-cycle experience in clinical data management (data collection system development through database lock and close-out)
- Ensuring trial information/results are reported within relevant trial repositories and tracking systems
- Ensuring that trial documentation is complete and accurate during the trial conduction
- Leading a team of clinical research associates and managing project coordinators
- Understanding of scientific studies experimental design, underlining scientific principles, and ability to analyze data and interpret results
4
Skills For Senior Global Trial Manager Resume
- Supporting forecast and management of drug supply
- Contributing to the creation and execution of an operational risk management plan
- Managing budget of each trial
- Motivating remuneration and many employee benefits1700180581W
- Motivating remuneration and many employee benefits1700180576W
- Managing internal and external customers as well as third part vendors
- Manage the operation of one or more trial teams, planning, organising and delegating work, monitoring progress and intervening as required
- Coordinate global DSM trial activities including planning and study set-up
5
Skills For Ex Global Trial Manager Resume
- Proficient in speaking and writing Czech and English language
- Proficient in speaking and writing Russian and English
- Ensure the delivery of the studies, adapting according to changes in workload and study requirements
- Undertake the training of others in areas relating to the team’s work
- Commits to process improvement initiatives and training and mentoring or other IIS team members
- Proficient in speaking and writing the country language and English language is required
6
Skills For Global Trial Manager Pre-approval Access Resume
- Ensures accurate project budget management and tracking according to plan. Updates project account with scope changes, if any
- Contributes to all operational trial deliverables according to timelines, budget, operational procedures, quality /compliance and performance standards
- Supports management and tracking of the trial level life cycle budget incl forecast, and annual cost targets
- Advise the Clinical Team on the optimal study supply strategy in terms of packaging design, technical feasibility, cost efficiency and risk minimization
- Negotiate over conflicting issues and develop win-win outcomes
- Conduct trial team meetings and provide or facilitate Trial Manager (TM)/Site Manager (SM) training when needed
- Ensure quality oversight and support of assigned IISs utilizing available tools
- Leads vendor assessment and selection in consultation with appropriate representatives of the operating company
7
Skills For Senior Trial Manager Resume
- Supports implementation of ARBM (Analytical risk based monitoring) model as applicable
- Supports SM in setting up action plan in case data entry timelines are not respected
- Monitors sites recruitment and set up action plan in collaboration with SM in case of non-enrolling sites
- Organization and logistics of various trial advisory committees
- Contributing to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); managing interface with CROs; ensuring vendors meet quality standards; contributing to the development/amendment of vendor contracts
- Contributing to the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan
- Contributes to all operational trial deliverables, under the oversight of the (Associate) Global Trial Director, according to timelines, budget, operational procedures, quality /compliance and performance standards
- Project manages study activities including
- In partnership with the Clinical Research Development Lead (CRDL), Epidemiologist , Country Medical Directors (for local studies), co-ordinates all members of the study network to ensure the appropriate experts (both central and local, operational and medical/scientific) are involved
8
Skills For Expert Global Trial Manager Resume
- Designing and implantation of the clinical operation strategy for assigned project
- Supervision of CROs and IIS
- Review clinical trial protocol and provides input to drug sections
- Liaise with Clinical Supply Documentation Specialist (CSDS) to define optimal label strategy
- Perform medication management and coordinate the distribution of clinical supplies for non-IRT trials
- Baseline Personnel Security Standard (BPSS)
9
Skills For Local Trial Manager M/F Resume
- The Senior Study Delivery Lead (sSDL) is the single accountable for the execution and delivery of
- Effective study team leadership skills and proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage study teams in a virtual environment are needed
- Proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage global or regional teams in a virtual environment are needed
- Abillty to work on multiple projects in parallel in different therapeutic areas is required
- Solid leadership skills. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills
10
Skills For Dsm Trial Manager Resume
- Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel
- Friendly and supportive team members and management
- Opportunities for professional growth and career development
- Possibilities to take part in different projects
- Effective study team leadership skills and proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage global or regional study teams in a virtual environment are needed
- At least 2‐3 years in SM position in the industry
- The sSDL is the reference and role model within study delivery lead team
- Clinical Data Management Experience; 2. Full life-cycle experience in clinical data management (data collection system development through database lock and close-out and submissions; 3. At least 1 year experience working with formal project management tools (MS Project) and processes
List of Typical Responsibilities For a Trial Manager Resume
1
Responsibilities For Local Trial Manager Resume
- Approves trial-level data validation plan (including project and protocol specific data validation elements)
- Acts as primary local contact in GCO for a trial. Establishes and maintains excellent working
- Act as primary local country contact for a trial. Establish and maintain excellent working relationships with
- Ensure trial information/results are reported within relevant trial repositories and tracking systems
- Ensure proper handling of all study close out activities
- Ensures timely decomissioning of clinical data management technologies
- Facilitates assessment and processing of standards and change requests.
2
Responsibilities For Global Trial Manager Resume
- Scientific writing ability
- Conducts accompanied site visits with SM as delegated by FM
- Contributes to process improvement
- Acting as point of contact for all site-related issues and procedural questions; Managing interactions with relevant line functions including data management, drug supply management, clinical development and Novartis Country Pharma Organizations
- Core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting; write CTT meeting minutes; can deputize for the (Associate) Global Trial Director
- Contributes to the development of study management documents at a country level or initiates development of these documents for trials which follow ED&CP Hybrid Oversight Model
- Ensures that all Serious Adverse Events (SAE)/Product Quality Complaints (PQC)/ Suspected Unexpected Serious Adverse Reactions (SUSAR) are reported within reporting timelines and documented as appropriate
- Accountable for set-up and conduct of Investigator Meetings (either local or multi-country) if applicable and collaborates with SM for site initiation visits
3
Responsibilities For Senior Local Trial Manager Resume
- Conducts trial team meetings and provides or facilitates SM training when needed and build key competencies (i.e. implementation of study amendment-and changes in study related processes)
- Reviews and approves Visit Reports submitted by SM within procedural timelines; identifies issues and/or trends across a trial/project and escalates deviation/issues to the GTL and FM as needed
- Prepares master informed consent and country specific informed consent(s) in accordance with GCO procedural document/templates. Reviews and manages site specific informed consent forms in accordance with GCO SOPs, other procedural documents and applicable regulations
- Organizes IEC/HA approvals, if applicable and ensures that the trial is in compliance with local regulatory requirements
- Works with SM to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits (e.g., On Site Quality Monitoring Visit (OSQMV))
- Relationships with external stakeholders, in particular investigators, trial coordinators, other site staff, key contacts in Early Development and/or Clinical Pharmacology and other internal stakeholders
4
Responsibilities For Senior Global Trial Manager Resume
- Actively contributes to process improvements initiatives, and training and mentoring of SMs and CTAs Conducts Accompanied Site Visits with SM as delegated by FM
- Ensures that all Serious Adverse Events (SAE)/Product Quality Complaints (PQC)/Suspected Unexpected Serious Adverse Reactions (SUSAR) are reported within reporting timelines and documented as appropriate
- Maintains and updates trial management systems. Uses study tools and management reports/dashboards available to analyse trial progress
- Monitors country and overall study progress (if applicable) and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to GPL, GTL and study management teams e.g. ensures appropriate documentation and follow-up related to protocol issue escalation
- Conducts trial team meetings and provides or facilitates TM/SM training when needed and build key competencies (i.e. implementation of study amendment-and changes in study related processes)
- Actively contributes to process improvement initiatives, and training and mentoring of SMs, CTAs and other TMs
- Monitors sites recruitment and sets up an action plan in collaboration with SM in case of non-enrolling sites
- Works with SMs to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits (e.g. On Site Quality Monitoring Visit (OSQMV)…)
5
Responsibilities For Ex Global Trial Manager Resume
- Assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”
- Represents functional area in process initiatives
- Accountable for budget oversight for assigned IISs including forecasting. Communicates budget discrepancies or payment delays with rationale to Operating Company representatives and the IIS Trial Manager Lead
- For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the IIS Trial Manager Lead and Study Responsible Physician/Study Responsible Scientist
- Contributes to process improvement initiatives and training and mentoring or other IIS team members
- Participates in preparing for or conducting Health Authority inspections and internal audits
- Supports the Global Trial Director with the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets
- Leads the SMT as the single point of accountability for end-to-end project management including trial set-up, execution, close-out, analysis and reporting
- Leads the SMT as the single point of accountability for end-to-end project management including trial set-up,
6
Responsibilities For Global Trial Manager Pre-approval Access Resume
- Overall project management of the Canadian component of multicentre, international registration studies and/or Medical Affairs studies (Phases 1-4)
- Accountable to Global study team for trial coordination and study deliverables
- Leadership of local study team. Contributions to local feasibility and investigator selection. Responsible for study start-up activities, subject recruitment and contingency plans at the country level, safety reporting, timely acquisition of quality data and trial documentation; study spend and forecast management
- Audit and inspection readiness
- Contribute to the development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement
- Strong project management skills with focus on study deliverables, trial/site oversight, quality and timelines
7
Responsibilities For Senior Trial Manager Resume
- Experience with overall trial management and risk based trial management is an asset
- Knowledge of several therapeutic areas is an asset
- Demonstrated skills in leadership and in the areas of judgement, communication, attention to detail, proactive problem-solving, analysis, negotiation, and innovation
- Strong prioritization, decision-making and adaptability skills. Ability to manage complexity and meet deadlines. Strategic, flexible and able to work well in a changing environment
- In coordination with the CPL/COH, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, the GTM provides adequate project-specific training to the GCO or CRO teams and to the site staff. Works with GCO/CRO staff in the set-up and coordination of Investigator Meetings, if applicable
- Leading P&G trial which includes all activation that directly target the consumer with promotions, demonstrations & sampling e.g. in-store promotions, all sampling activities, roadshows etc
8
Responsibilities For Expert Global Trial Manager Resume
- Development and management of creative direct to consumer trial strategies. Handle and implement trial plans together with BTL agencies to ensure reach targets are achieved
- Have at least 3 years experience in an operations role at BTL agency
- Experience in clinical development
- Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate
- Lead, control and track all infield executions with 100% delivery of executions on time with quality
- Build effective business relationships with stakeholders both internally (Brand/Business teams) and externally (BTL agencies) through handling expectations, clear communication and consistent performance
- Monitoring competitive activities, and delivering key insights to ensue competitive trial strategies
9
Responsibilities For Local Trial Manager M/F Resume
- Sample management – from handling production & supply with regional teams to distribution to agencies and finally consumers
- Keep up to date with market & industry changes and alert the team of potential advantages/new opportunities
- Support forecast and management of drug supply for Novartis and comparator drug products in collaboration with internal stakeholders
- Contribute to the development of clinical outsourcing specifications to facilitate bid process and selection of Contract Research Organizations (CROs); manage interface with CROs in cooperation with outsourcing management and line functions; ensure vendors meet quality standards; contribute to the development/amendment of vendor contracts
- Support the development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis plan
- Implement issue resolution plans and act as point of contact for all site-related issues and procedural questions
10
Responsibilities For Dsm Trial Manager Resume
- Manage interactions with relevant line functions
- Support the Global Trial Director with the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets
- Be a core member of the global cross-functional Clinical Trial Team (CTT); participate and report study progress and issues/resolution plan at the CTT meeting and write minutes; organize and chair trial sub teams within the scope of his/her delegated responsibilities. Extended member of the Global Clinical Team (GCT)
- Responsible for (SOPs) and best practices for trial management
- Involvement in cross-functional, multicultural and international clinical trials; demonstrated capabilities in supporting operational aspects of clinical trial related activities
Related to Trial Manager Resume Samples
Intake Manager Resume Sample
Work Experience
• Lead, maintain, and continuously improve the gating process for applicable projects in the Canadian and International portion of the program
• Collaborate with US CPO counterpart to lead and guide the enterprise gating sessions
• Maintain master schedule, a repository of gati...
Professional Skills
• Interpersonal skills needed to effectively...
• Qualitative and quantitative analytical sk...
• Intermediate PC skills including MS Word, ...
Lean Manager Resume Sample
Work Experience
• Creating an efficient, effective, and dependable set of processes for the elimination of waste in all areas of the company
• Actively pursuing continuous improvement strategies aimed at reducing costs, increasing customer satisfaction, and improving financial performance
• Wo...
Professional Skills
• Excellent written and verbal communication...
• Excellent problem-solving skills with a pr...
• Excellent communication skills (verbal and...
Transition Manager Resume Sample
Work Experience
• Coordinate the business readiness plan, taking into consideration IT deployment, data migration, capability deployment (training and engagement activities) and any business activities required to integrate new processes or jobs into the ’business as usual’ environment
• Comfortable leading discussi...
Professional Skills
• Excellent communication, presentation, and...
• Strong skills and experience in managing c...
• Strong influencing and negotiation skills,...
Servicing Manager Resume Sample
Work Experience
• Experience in the asset management industry
• Good product knowledge in multi-asset class
• Mature, strong communication skills and detailed-oriented
• Leading a team to ensure the timeliness and accuracy of Corporate Action and Dividend Payments to Cit...
Professional Skills
• Proven Leadership and Employee Management ...
• Proven Leadership and Employee Management ...
• Strong focus on Client service/experience ...
Manager, Enterprise Resume Sample
Work Experience
• Thorough knowledge of the bank’s PMO methodologies and project lifecycle stages
• Three to five years’ experience in leading the Implementation, enhancements, and support of Concur in a large scale enterprise-wide regulated environment. This includes
• Development of business...
Professional Skills
• Proven leadership skills with the manageri...
• Strong communication and interpersonal ski...
• Communicate effectively and presentation s...
Mgr Capture Management Resume Sample
Work Experience
• Lead/Support Raytheon’s business proposal activities
• Leadership experience as an international capture/BD Lead for pursuits with experience in successful business captures in the airborne ISR market
• Direct experience in successfully working with systems controlled under t...
Professional Skills
• Experience with customer focused marketing...
• Demonstrated experience leading capture ac...
• Strategic planning and demonstrated relate...