Clinical Project Leader Resume Sample
Gabe Cremin
348 Boyer Burg,
Houston,
TX
+1 (555) 307 6144
Work Experience
Clinical Project Leader
02/2016
-
PRESENT
New York, NY
- Participate in conjunction with the principal investigator in initial contacts with outside vendors and internal functional groups for potential projects including early trial budget negotiations and contract and proposal development
- Manages and responsible for project budgets in concert with project team and financial analyst
- Manages assigned staff, develops, writes and completes individual employee performance improvement plans, completes employee evaluations in appropriate time frame, manages assigned employee career progression
- Recommend and develop guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assist in the determination of guidelines for new protocols
- Develops CEC project plan in concert with team members to include time lines, and processes for clinical research studies, milestones, DMC activities; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocol and CEC Charter as appropriate
- Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations (if applicable); assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate
- Develop and implement training and new processes in CEC to ensure consistency in work flow and CEC SOPs
- Facilitate development of study tools and appropriate tracking systems for coordination of trials, grants, enrollment status and clinical supplies. Ensures adherence to contractual
- Planning, coordinating, and tracking the site start-up activities
Clinical Trials Project Leader
06/2009
-
11/2015
Detroit, MI
- Reading and understanding project protocol documents
- Quality review the entry and maintenance of data in the applicable study tracking database
- Participating in project meetings, conference calls, and training or troubleshooting calls by providing study status updates to internal and external stakeholders
- Ensures the confidentiality of study protocols and subjects is maintained
- Ensures security of all study data and study/regulatory documents
- Acting as backup to the Assistant Clinical Project Manager as needed
- Participate in feasibility studies with the Medical Advisor
Clinical Operations Project Leader
03/2003
-
04/2009
Detroit, MI
- Produce, implement, analyze and follow recruitment plans and key milestones for the studies for which he/she is responsible
- Periodically inform the members of the team in charge of the study (Global and/or local)
- Facilitate research meetings with various departments in Medical Department
- Oversee research projects, ensuring completion on schedule and within budget
- Ensure that all clinical studies are conducted according to Good Clinical Practice, ICH, Standard Operating Procedures, local laws, and Policies and Procedures
- Anticipate project requirements and institute appropriate actions to ensure timelines and budget are met
- Organize study specific training for the project team and study staff as needed
- Accompany CRAs on pre-study, initiation, routine monitoring and close-out visits of study sites, when necessary
Education
Argosy University - Twin Cities Campus
1998 - 2003
Bachelor's Degree in Public Health
Professional Skills
- Demonstrates clear and concise verbal and written communication skills for both internal and external audiences
- Team player, good interpersonal skills, confidentiality, teamwork attitude, problem solving, customer orientation
- Excellent knowledge/experience of the Monitoring Process
- Proven working experience in project management required
- Demonstrated knowledge in several relevant therapeutic areas; experience in rare disease indications is an advantage
- Advanced computer skills in Word, Excel, PowerPoint, and Project
- Exhibits ability to manage a heavy workload by prioritizing appropriately
How to write Clinical Project Leader Resume
Clinical Project Leader role is responsible for training, credit, database, security, reporting, manufacturing, design, research, travel, events.
To write great resume for clinical project leader job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Clinical Project Leader Resume
The section contact information is important in your clinical project leader 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 Clinical Project Leader Resume
The section work experience is an essential part of your clinical project leader 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 clinical project leader responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical project leader position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Clinical Project Leader resume experience can include:
- Self-motivation, results driven, detail-oriented and good organizational skills
- Performance Development, develop personal and technical skills in line with the Curriculum map and with the aid of the supervisor
- People, Change and influence management skills
- Good understanding of the Data Management Process
- Strong competency in the areas of clinical study design, statistics, technical writing
- Actively work towards achieving good relationships with all local Study Team members
Education on a Clinical Project Leader Resume
Make sure to make education a priority on your clinical project leader resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical project leader 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 Clinical Project Leader Resume
When listing skills on your clinical project leader 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 clinical project leader skills:
- Solid analytical and proactive problem-solving skills
- Proven track record with leading teams on high priority projects
- Nursing or biological science qualification, or equivalent combination of education and work experience
- Good understanding of the Study Drug Handling Process
- Experience with ethics submissions, IRAS & NIHR costing template
- Excellent understanding of the Clinical Study Process
List of Typical Experience For a Clinical Project Leader Resume
1
Experience For Clinical Trials Project Leader Resume
- Maintain business operations in accordance with corporate policies with respect to pricing, quotes, credit terms, and expense reporting
- 6 Budget ensures payments are done according to contracts
- Organize and participate in investigators or study meetings, as needed
- In conjunction with the function leads within the CSO, builds study teams that are adapted to meet project’s needs/requirements
- Contribute to strategy and plans set up at global and local
- Prepare CTD for J-NDA and Respond to Questions by PMDA
- Excute agreed plans and deliver outcomes in time
2
Experience For Clinical Sciences & Operations Project Leader Resume
- Logistic and technical expert support to clinical department, attendance to patients’ follow-ups, collection of technical and clinical data on CRFs on site, ensure to achieve the enrollment plans
- Team work & Attitude, implementation of all new systems necessary for the studies. Support group initiatives in cooperation with other relevant team members
- Customer Orientation & Communication, Main point of contact for the study. Efficiently communicate expectation to the site and get agreements in critical points. Communicate effectively with all members of the team locally, globally and with the investigator sites
- 5 Frequent travel to visit investigational centers (Local and foreign countries) and to attend meeting with project team and/or operational/functional organization
- 7 Administrative task related to the successful progress of the study under supervision of Clinical Managers with other involves CRAs or CFEs
- Proactively plan their weekly travel schedule and communicate this through the appropriate channels in your country/division
- Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA
3
Experience For Clinical Operations Project Leader Resume
- In collaboration with Line Manager(s),
- Lead and optimise the performance of the Local Study Team(s) at country level ensuring compliance with sponsor Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
- Proactively identify and facilitate resolution of complex study problems and issues
- Organise regular Local Study Team meetings on an agenda driven basis
- Report study progress/update to the Study Management Organisation (SMO) Study Leader/Team
- Plan and lead national Investigator meetings, in line with local codes
- Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan
4
Experience For Project Leader, Clinical Trials Dcri Resume
- Ensure timely preparation of country Study Management Agreement (SMA), country fSMA and country Master CSA
- In collaboration with the local study team, ensure completeness of the electronic Trial Master File and/or paper Trial Master File on country and site level, and ensure essential documents are sent to SMO/Hub location/site
- Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers
- Ensure timely submission of proper application/documents to EC/IRB
- Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority
- Set up and maintain the study in IMPACT and/or other Clinical Trial Management System, at study country level
5
Experience For Clinical Trials Project Leader, Dcri-outcomes Resume
- Ensure accurate payments related to the study are performed
- Plan and lead activities associated with audits and regulatory inspections in liaison with Line Manager, Clinical Process Manager and CA&A
- Provide input to process development and improvement
- Provide regular information to SMM Director/CRM at country level on study/ies and planned study milestones/key issues
- Update SMM Director/Clinical Research Manager (CRM) about the performance of the monitors/CRAs
- Ensure that study activities at country level comply with Sponsor’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)
6
Experience For Project Leader Academic & Clinical Programs Resume
- Assist SMM Director/CRM in efficient functioning of department at country level
- Liaise with Local Compliance Officer regarding payments to Investigators to ensure these are in accordance with local requirements
- Prepare and maintain study budget at country level in ACCORD
- Timely preparation and support to process of registration of applicable clinical studies in country-specific or regional websites
- Ensure that clinical and operational feasibility assessment of Study Design Concept and Clinical Study Protocol is performed to highest quality
- Support SMM region in initiatives as agreed with SMM Director/CRM
7
Experience For Clinical Trials Project Leader, Ctsi Resume
- Oversees study vendors and contractors to ensure clinical trials are executed with high quality and within timelines and established budget parameters
- Ensures clinical trials are executed in compliance with GCP and regulatory expectations
- Leads project specific meetings with executive management team
- Identifies operational issues across protocols and ensures resolution
- Implements best industry practice standards across assigned studies
- Provides strategic and tactical guidance in risk management
8
Experience For Clinical Project Leader and Resume
- Provides guidance on the development and implementation of clinical protocols within the project
- Engages in corporate partnership alliance relationship management, as applicable
- Negotiates vendor contract terms and ensures proper execution
- Leads vendor selection activities; establishes vendor oversight expectations and ensures proper execution of the vendor management plan; establishes and monitors Key Performance Indicators
- Participates in process improvement initiatives to increase quality, productivity, and efficiency of the Clinical Trial Management functions
- Participates in Quality Assurance efforts
- Regularly reports project status, resource requirements and staff performance to the Head of Clinical Operations
- Anticipates project needs and implements solutions
9
Experience For Manager, Clinical Project Leader Resume
- Escalates issues when appropriate
- Ensures optimal relationships with key internal partners and stakeholders to enable successful execution of trials
- Maintains clinical trial management expertise through clinical trial literature review, ongoing awareness of industry practices and participation in professional activities
- Facilitates vendor training on applicable GEHC SOPs
- Utilizes appropriate IT systems and ensures that clinical trial team utilizes and updates systems and tools to enable successful trial execution
10
Experience For Clinical Project Leader for Cras Resume
- Travel is variable and estimated at 20%
- Influence others and resolve dynamic tensions
- Think globally and strategically, while maintain adequate knowledge of clinical trial details
- Identify and execute staff development strategies
- Participates in selection process of external Service Providers (SPs)
- Translates technical requirements from R&D project teams into scope of work for execution by SPs
- Creates a culture of joint accountability to ensure Vendor performance
- Facilitates efficient and collaborative resolution of problems and conflicts with SPs and on behalf of SPs within Life Sciences
- Facilitates final quality check for all operational processes associated with specific engagements and accountable for aligning engagement deliverables to GEHC policies and procedures for operations, compliance, and outsourcing
List of Typical Skills For a Clinical Project Leader Resume
1
Skills For Clinical Trials Project Leader Resume
- Proven track record for making sound decisions
- Demonstrates the ability to step back from details and see the bigger picture
- Demonstrates initiative to deal with unfamiliar situations
- Demonstrates a "can do" attitude
- Clinical laboratory experience or clinical research required
- Previous clinical trial experience is desirable
- Travel domestically and internationally and have a valid driver’s license
2
Skills For Clinical Sciences & Operations Project Leader Resume
- Experience in Clinical Laboratory Science
- Experience in Clinical Laboratory Science is required
- Demonstrated self-starter with a high level of commitment
- Builds strong relationships to maximize performance and value delivered by SPs
- Develops, maintains and shares Good Vendor Management Practices
- Maintain good communication with sites through telephone calls, emails and correspondence
- Build strong relationships to maximize performance and value delivered by SPs
- Develop, maintain and share Good Vendor Management Practices
3
Skills For Clinical Operations Project Leader Resume
- Willing to travel oversea and domestically
- Utilize available tools, such as Microsoft Project, to assist in planning and structuring research activities and processes
- Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team
- Participate in training and coaching new members of the Local Study Team
- Participates in the development and management of project budgets; proactively manages study budgets, including accurate forecasting and cost accruals
- Knowledge of TGA regulations pertaining to clinical trials and adverse event / adverse device effect reporting requirements
4
Skills For Project Leader, Clinical Trials Dcri Resume
- 7. Help in identifying site/protocol trends to execute adequate action plans
- Facilitate and guide communications/interactions among project team members, the Steering Committee, Executive Committee, and the Executive Director
- Assist in the writing/preparation of abstracts, manuscripts, and presentations
- Ensure that all study documents are ready for final archiving and sign-off
- Cardiological science, clinic and/or physiology, pacing/defibrillation technologies
- Responsible for routine reporting of the project’s status to the team & platform
- Problem solving & innovation, this job requires that the incumbent identifies and analyses problems, makes timely proposals for solutions and decisions
- Lead Local Study Team(s) consisting of monitors and study administrator(s)
5
Skills For Clinical Trials Project Leader, Dcri-outcomes Resume
- Perform any required co-monitoring & QC visits with study monitor(s)
- Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters
- Contribute to patient recruitment strategy with monitors, including regular communication with concerned Investigators as necessary
- Communicate and co-ordinate regularly with National Co-ordinating Investigator/National Lead Investigator on recruitment and other study matters
- Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites
6
Skills For Project Leader Academic & Clinical Programs Resume
- Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs
- Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File
- Flexible to an ever-changing environment
- Builds a general understanding of our SPs, their organization and capabilities to anticipate opportunities & risks
- Performs Pre-Selection, Initiation, Monitoring, and Closeout site visits
7
Skills For Clinical Trials Project Leader, Ctsi Resume
- Negotiates and tracks center/trial budget according to financial agreement with each centre
- Assists in the tracking of subject enrollment at each trial site, and provides management with detailed reports of clinical activities, as requested
- Ensure protocol compliance as well as compliance with relevant national regulations, including ICH GCP
- Conduct site qualification and initiation visits, routine monitoring visits, and study close-out visits
- Assist in preparation of monthly tracking reports for project management
- Proficient in using Microsoft Office Suites ie Word, Excel, Powerpoint
- Build a general understanding of our SPs, their organization and capabilities to anticipate opportunities & risks
- Oversees performance of Pre-Selection, Initiation, Monitoring, and Closeout site visits
8
Skills For Clinical Project Leader and Resume
- Assist SMM Director/ Clinical Research Managers in efficient functioning of department at country level
- Actively participates on non-research project initiatives
- As necessary, consistent with project needs
- Exhibits ability to adapt communication style and approach to circumstances,particularly when addressing concerns or proposing a solution.Organizational Leadership
- Actively participates on non-research project initiatives.Accountability Identifies and follows through on opportunities for self-improvement
- Actively participates on non-research project initiatives.Accountability
- Appropriately solicits advice and guidance in areas outside of his/her expertise
- Actively promotes a timely resolution of all operational issues and problems and ensures that appropriate individuals are included in the discussion
- Discusses problems immediately before they have gotten out of control
9
Skills For Manager, Clinical Project Leader Resume
- Considers impact of decisionson project timelines, quality, and costs
- Recognizes issues that would put a project at risk and alerts the Executive Director
- Listens well and is open to suggestions from team members
- Encourages open and honest communication
- Accepts responsibility for outcomes of work even if task was delegated
- Admits mistakes and refocuses efforts
- 8. Budget, define cost and help to identify resources needed for study implementation
- 1 Logistic and technical expert support to clinical department, attendance to patients’ follow-ups, collection of technical and clinical data on CRFs on site, ensure to achieve the enrollment plans
10
Skills For Clinical Project Leader for Cras Resume
- 2 Supports physicians during the enrolment and follow up phase of clinical studies. Detect and escalate any issues related to the study site, in a systematic and timely manner. Design, propose and implement actions plans to address identified issues
- 3 Perform stand duty
- 4 Train sites in CRF's completion as well as how to answer to queries correctly and the relevance and their responsibility to provide a timely response to queries
- In collaboration with executive-level Team Leader(s), assist in the development of project plans for concepts approved by the Executive Committee Develop task lists, list of skills needed in team members, and estimated human and financial resources needed for new project plans
- On assigned research projects, serve as the central person responsible for facilitating the activities of a "virtual" project team composed of individuals from a variety of sectors, such as FDA, industry (drug, device, biologic, or CROs [clinical research organizations]), investigator groups, NIH, professional societies, and patient representatives
- Coordinate and manage all aspects of selected CTTI projects, ensuring adherence to project timeline, budget, and deliverables
- Work with the team leader and members to develop, coordinate, and implement research strategies to ensure successful management of each project
- Notify the Executive Director if there is modification of project timeline in absence of "out of scope" activities
List of Typical Responsibilities For a Clinical Project Leader Resume
1
Responsibilities For Clinical Trials Project Leader Resume
- Experience in clinical investigation in pharmaceutical or medical device industry- Experience in the biomedical field
- Excellent knowledge of international guidelines - ICH-GCP
- Good knowledge of relevant local regulations
- Good medical knowledge in relevant AstraZeneca Therapeutic Areas
- Excellent knowledge in Clinical Operations
- Represents CSO when collaborating and goal setting with other platforms and enabling functions in order to successfully meet the requirements of the project
- Ensures that these trials are carried out according to the required quality standard deadlines and to the CSU’s commitments
- Performs initial contact and participates in the assessment and selection of qualified investigators for inclusion in clinical programs
- Contributes to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports
2
Responsibilities For Clinical Sciences & Operations Project Leader Resume
- Collects and processes regulatory documents and correspondence
- Ensures that clinical trial sites have adequate supplies to perform the trial
- Act as SMT leader to provide direction and leadership to medical clinical studies
- Assure the quality of designated clinical projects
- Allocate the budget for clinical trials
3
Responsibilities For Clinical Operations Project Leader Resume
- Support physicians at conferences to put together accurate presentations
- Ensure programs meet status and compliance as per Company clinical strategies, procedures and policies
- Ensure accurate and complete collection of data on case report forms through source document verification of data
- Ensure sites complete data queries in a timely manner
- Participate in investigator meetings
- Knowledge of ICH GCP Guidelines and their implementation
- In case the employee is being made aware of an event or complaint in relation to a product distributed by ABBOTT, he/she shall report this in compliance with the SOP 50558 on Field Event Reporting
- Assesses the impact of the project on the platform
- Sets team goals and provides performance reviews for the team
4
Responsibilities For Project Leader, Clinical Trials Dcri Resume
- Provides oversight for and is accountable for project performance to ensure it meets the project expectations as far as timelines, quality and budget. Makes adjustments to the plan and/or team as required
- Anticipates project risks and develops and implements a risk management plan to minimize negative impact in fulfilling project deliverables
- Leads the discussion on the choice of vendors for outsourced programs, provides input into vendors used for specific activities and is accountable for deliverables of full-package outsourcing
- Contributes to CSO business expansion and to developing the CSO catalogue for services
- Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings, ensure enrollment criteria are met and other
- Participate in selection process of external Service Providers (SPs)
- Translate technical requirements from R&D project teams into scope of work for execution by SPs
- Facilitate efficient and collaborative resolution of problems and conflicts with SPs and on behalf of SPs within Life Sciences
5
Responsibilities For Clinical Trials Project Leader, Dcri-outcomes Resume
- Facilitate final quality check for all operational processes associated with specific engagements and accountable for aligning engagement deliverables to GEHC policies and procedures for operations, compliance, and outsourcing
- Facilitate vendor training on applicable GEHC SOPs
- Prepare and maintain study budget at country level
- Support SMM region in initiatives as agreed with SMM Director/ Clinical Research Managers
- Accurate, well-organised, technical, able to work alone
- Represents a privileged link between the International Clinical Development and the CSU within the framework of these clinical trials
- Participates in the assessment of the trial feasibility
- Makes a selection of investigators
6
Responsibilities For Project Leader Academic & Clinical Programs Resume
- Prepares the file submission
- To the Health Authorities
- Clinical investigation in pharmaceutical industry, medical device or CRO
- Aware of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Fluent knowledge of spoken and written English
- Develop systems for the establishment and refinement of guidelines in the collection of clinical data and administration of clinical trials; design and evaluate alternative methodology as necessary
- Advise and assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate
7
Responsibilities For Clinical Trials Project Leader, Ctsi Resume
- Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate
- Coordinate and lead the work of the Project Leader I and II staff and research team and provide feedback to staffs supervisor on a routine basis; conduct cross functional research team meetings as needed
- Advise and assist the principal investigator in initial contacts and development of relationships with outside partners and internal functional groups for potential projects including trial budget and contract negotiations
- Demonstrated ability to operationally manage several projects concurrently
- Both leadership and management experience required
8
Responsibilities For Clinical Project Leader and Resume
- Participates in/organizes the kick-off meeting
- Review and translate scientific data required
- Excellent communication skills, both spoken and written. Experience communicating with senior executives in both a private and academic setting towards development of new therapeutics
- Experience with FDA submissions and audits
- Knowledge of scientific methodologies and clinical laboratory science
- The position is in contact with Customers
- Lead and optimise the performance of the Local Study Team(s) at country level ensuring compliance with AstraZeneca Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
- Report study progress/update to the Study Leader/Team
9
Responsibilities For Manager, Clinical Project Leader Resume
- Ensure timely preparation of country SMA and country Master Clinical Study Agreement
- In collaboration with the local study team, ensure completeness of documents on country and site level, and ensure essential documents are sent to relevant site
- Ensure timely submission of proper application/documents to Ethics Committees
- Set up and maintain the study in the Clinical Trial Management Systems, at study country level
- Plan and lead activities associated with audits and regulatory inspections in liaison with Line Manager, and Clinical Process Manager
- Provide regular information to SMM Director/Clinical Research Managers at country level on study/ies and planned study milestones/key issues
- Update SMM Director/ Clinical Research Managers about the performance of the monitors/CRAs
- Ensure that study activities at country level comply with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)
- Develop and maintain partnerships with CRO’s, clinical vendors and investigators
10
Responsibilities For Clinical Project Leader for Cras Resume
- Assist in the identification and solicitation of in-kind and financial resources required to complete a project
- Maintain awareness of various stakeholder perspectives applicable to a project and identify strategies to engage multiple stakeholders in the project
- Work with team members to submitprotocols for IRB review, if applicable, and maintain currency of all regulatory requirements for all projects
- Work with Executive Director and team leader on all contractual issues. This includes managing subcontracts, reviewing and approving submitted invoices, and tracking subcontractor adherence to timeline and deliverables
- Prepare a variety of narrative and analytic reports, documents, and correspondence for CTTI leadership, team leader(s), and team members regarding project status; recommend corrective action as necessary
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