Study Manager Resume Sample
Ignatius Lemke
1306 Kaitlin View,
Houston,
TX
+1 (555) 630 7184
Work Experience
Study Manager
07/2016
-
PRESENT
Los Angeles, CA
- Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD.
- Identify resource need and secure resources from various departments, timely form a motivated and
- Accountable for the development of realistic detailed study startup and monitoring plans
- Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans
- Leads study risk planning process in context of site and subject
- Coordinates study/protocol training & supports investigator meetings
- Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
- Accountable for the delivery of the study or subset of agreed study activities against approved plans
Senior Study Manager
12/2009
-
03/2016
New York, NY
- Leads inspection readiness activities related to study management and site readiness
- Advanced theoretical knowledge in public health, exercise science, psychology, or related field with extensive theoretical knowledge in health behavior change as it relates to physical activity and diet
- Strong experience in project development and coordination, strategic planning, grant writing and development. Ability to contribute important original ideas pertaining to the planning, development, modification, and execution of new research studies and ancillary studies that build on existing work
- Superior computer skills including knowledge of PC software applications such as Word and Excel to produce manuscripts, reports, correspondence, graphs, and spreadsheets to generate, track, and analyze required data. Ability to navigate and utilize email systems and internet to conduct searches, etc
- Strong leadership and management skills. Decision-making skills and ability to use independent judgment to quickly set priorities and to solve problems. Ability to respond effectively to unexpected events and crises
- Demonstrated knowledge of wireless technology applications as persuasive devices in physical activity and dietary related research
- Advanced knowledge of experimental protocols, data gathering, protocol design and evaluation. Demonstrated extensive experience in research protocol start up procedures
- Strong knowledge of biostatistics and superior data analysis skills, including proficiency in SAS or other statistical software package
Global Study Manager
07/2005
-
09/2009
Chicago, IL
- Strong practical knowledge and experience in developing, implementing, and managing behavioral research
- Demonstrated knowledge of physical activity, diet/nutrition, and scientific terminology
- Advanced practical knowledge and experience in the design, maintenance and innovation of physical activity and dietary intervention trials
- Thorough knowledge of and experience with IRB regulations, Human Subjects Rights and informed consent procedures, including issues related to competency to consent
- Excellent written (using correct English grammar, spelling, and punctuation), verbal and interpersonal communication skills including tact, diplomacy, and flexibility in order to work effectively with co-workers, supervisor, investigators at other sites, study participants, and local university administrators, and UCSD and NHLBI regulatory personnel
- Experience in prioritizing workload independently and giving direction to other team members. Excellent organizational skills. Strong experience in planning meetings and decision making. Proven ability to facilitate meetings
- Three (3+) or more years of health coaching experience within a wellness program. Knowledge of physical activity, diet/nutrition, and scientific terminology
- Demonstrated extensive experience in research protocol start up procedures. Strong practical knowledge and experience in developing, implementing, and managing behavioral research
- Strong experience in project development and coordination, strategic planning, grant writing and development
Education
Argosy University, Chicago
2000 - 2004
Bachelor's Degree in Public Health
Professional Skills
- For Global/Regional Studies(referred to in rest of this document as Global), the CSM leads and has full accountability (time, quality, cost) of all Affiliate related aspects of a study and ensures delivery of country/regional operational aspects in alignment with the study plans provided by the global Study Management Team (SMT)
- Negotiation skills, presentation skills and the ability to work in a fast-paced team environment
- Demonstrated strong customer service skills and client expertise
- Excellent written, verbal, and strong interpersonal skills
- Possess excellent report writing and editing skills
- Strong planning, organizational, negotiation and problem solving skills
- Strong organization skills and attention to detail,
How to write Study Manager Resume
Study Manager role is responsible for software, english, interpersonal, leadership, word, computer, planning, database, analysis, design.
To write great resume for study manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Study Manager Resume
The section contact information is important in your study 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 Study Manager Resume
The section work experience is an essential part of your study 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 study 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 study manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Study Manager resume experience can include:
- Contribute important original ideas pertaining to the planning, development, modification, and execution of new research studies and ancillary studies that build on existing work
- Strong demonstrated experience in planning meetings and decision making. Demonstrated ability to facilitate meetings
- Strong knowledge of biostatistics and superior data analysis skills, including proficiency in a statistical software package
- Work effectively in a matrix structure, liaising with and securing resources from functional heads and working groups
- Commitment to leading and mentoring study managers and study engineers to develop their capacity and skills
- Demonstrated experience in managing per subject costs, vendor &; ancillary, and monitoring costs projections and spend
Education on a Study Manager Resume
Make sure to make education a priority on your study manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your study 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 Study Manager Resume
When listing skills on your study 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 study manager skills:
- Excellent written and oral communication skills and interpersonal skills; Problem-solving skills
- Strong oral presentation, and excellent interpersonal, decision-making and issue resolution skills
- Detail-oriented with excellent organizational and prioritization skills
- Excellent oral (including presentation) and written communication, computer/database management and project management skills
- Prioritize effectively and respond to urgent requests from within the project team
- Proven study management skills and study leadership abilities
List of Typical Experience For a Study Manager Resume
1
Experience For Senior Study Manager Resume
- Work independently, accurately with attention to detail, maintain confidentiality, and function effectively under deadline pressures to fulfill assignments on schedule. Excellent organizational skills
- Superior computer skills including knowledge of PC software applications Word and Excel to produce manuscripts, reports, correspondence, graphs, and spreadsheets to generate, track, and analyze required data. Ability to navigate and utilize email systems and the internet to conduct searches, etc
- Good knowledge of ICH GCP and SAGCP, quality standards related to study management
- Overseeing and implementing risk management plans, study budgets and resource planning to ensure your study team's trial data is accurate and complete
- Liaising with the study management teams (local and/or global) and local business associates, key stakeholders and CROs as relevant
- Identifies and develops metrics and operational tracking tools to support the operations team and for reporting to senior management on clinical trial conduct
2
Experience For Country Study Manager Resume
- Advanced knowledge of experimental protocols, data gathering, protocol design and evaluation
- Conceptualize and solve both complex and uncomplicated problems by making decisions that are aligned with results of in-depth analysis of available information
- Leadership: developed through leading multi-functional matrix study teams through all stages of clinical studies would be preferable
- Liaise with R&D, Quality, Contracts, Project Teams, Clinical Operations, Marketing and Vendor Management
- Has full accountability for all assigned studies at Regional/country level (Global and local studies) including adherence to quality, timelines and budget
- Has full accountability for all assigned studies at country level including adherence to quality, timelines and budget
- Leads the local study team, including cross functional group leaders, and ensures GLORA process is followed
3
Experience For Global Study Manager Resume
- Manages study budget and invoicing activities to ensure these aspects are always aligned
- Maintains up-to-date project status parameters within the company electronic tracking tools and databases
- Creates forecasts and packaging design based on study needs to ensure optimized supply plan in terms of cost, feasibility and overage
- Leads process improvement initiatives and training efforts as a clinical supplies SME
- Manage and direct designated study teams to ensure profitability and reimbursability using best practice systems and processes
- Progress reporting both internally and towards Client
4
Experience For Local Study Manager Resume
- Responsible for study deliverables, such as system engineering documentation, cost and schedule estimates, risk evaluation, and study report
- Participates as requested in the development of SOPs and department level training
- Clinical development experience on the operational aspects of conducting clinical studies including: vendor/CRO resource management, leading/working as part of a development team, implementing clinical development plans, risk management
- Personal Organisation: demonstrated ability to prioritize and manage multiple tasks, self-motivated and achievement driven as well as ability to influence and negotiate at all levels to achieve team delivery
- Budget acumen that allows for preparation and tracking of study budget both pre and during study conduct
- Assure that the supply for clinical biospecimens fulfills the customer’s needs
- Serve as study manager for internal and external biospecimen acquisitions
- Perform all study Sponsor's activities for biospecimen collection programs/ protocols whether for BD associates or external sites (eg, oversee IRB submissions for BD Associate Sample Collection Programs)
5
Experience For CTS Study Manager Resume
- Maintain databases for BD Associate Sample Collection Program (ASCP) and external vendor biospecimen acquisitions
- Ensure programs are monitored on a regular basis
- Identify and qualify external sites / vendors for biospecimen services and maintains a list of qualified sites/vendors
- Relevant healthcare experience of which 5 years working in early clinical operations pharmaceutical including direct monitoring and clinical trial/study management experience
- Professional experience: at least 4-5 years’ relevant experience in clinical supply management or R&D project management
- Builds effective, high performing LSTs through influence, integration, motivation and optimization of team performance. Embeds the Roche values into the team(s) culture and promotes the team spirit
6
Experience For IIT Study Manager Resume
- Sets the LST goals and ensures goals are in line with the operational strategy agreed by Clinical and Study Management Teams. Provides coaching to the team to facilitate the setting and achievement of goals
- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, e.g. Pharma Business, GSM, functional management
- Liases with other functional groups to ensure the LST(s) members and monitors receive appropriate therapeutic area and study specific training
- Ensures that each team member is aware of his/her specific area of accountability and responsibility within the LST
- Manages and coaches performance of study team members by setting expectations, supporting team members, monitoring performance, providing feedback and following up, when appropriate to ensure performance is optimized
- Represents the LST(s) at the SMT
- Maintain awareness of external clinical research practices to ensure the LST(s) and monitors are aware of the risks, priorities, value and impact of their work and contributions
- Development/management/reconciliation of overall study budget(s) Development/management of vendor scope of work (SOW) per contract, quality, and budget
- Review/approval of vendor invoices and management of accruals and SOW changes
7
Experience For Los Bronces Underground Study Manager Resume
- Leads local study teams, represents Country Clinical Operation
- Accountable for successful delivery of assigned clinical trials projects. Ensures that study specifications and deliverables are consistent with corporate and client expectations. Ensures that scope and timelines are clearly documented and agreed, according to client, protocol and internal requirements
- Coordinates and implements plans associated with kits and logistics, specimen management, data management, laboratory operations and third party vendors, as required. Coordinates timelines and resource requirements with other functional areas
- Ensures that validation and quality control requirements are fulfilled and documented on time and in accordance with standard operating procedures. Ensures all required internal and sponsor approvals are obtained
- Organizes kick-off meetings and/or training sessions as required to communicate study requirements internally and externally. Documents all required study training in project files
- Travels as required to attend Investigator meetings, client and/or site meetings to provide instruction on specimen collection, packaging and shipping procedures
8
Experience For Toxicology External Study Manager Resume
- Interacts with Project Team members to resolve and troubleshoot problems related to specimens, result reporting and site compliance. Provides Sponsors and/or Investigators with resolution to problems or referral to appropriate sources
- Reviews status of assigned projects through regular Project Team meetings. Provides additional updates and metrics as required to Supervisor, Business Development and/or Alliance Manager in support of broader global program oversight
- Proactively manages and anticipates risks to successful project delivery and escalates issues promptly in accordance with global escalation policy
- Maintains clear and frequent communication with the client and supervisor to provide project status updates
- Interacts with Clinical Trials Quality Assurance when need to participate in audits, inspections and other QA/QC issues. Responds promptly to requests for information associated with these activities
- Completes all tasks in accordance with standard operating procedures and policies, and assists in assuring ongoing compliance within the project team. Maintains up-to-date personnel file including all required training documentation
- Oversees all aspects of clinical supplies management ensuring there are sufficient supply levels at sites and depots
- Represents clinical supplies function at clinical trial team meetings; communicates plan and timelines to internal and external customers and partners
- Reviews clinical trial protocol and provides input to clinical supplies and IRT sections
9
Experience For Pre-study Manager Resume
- Proactively drives the labeling, packaging, release, distribution and return of clinical supplies for assigned studies, ensuring the project timeline is met or exceeded
- Participates in cross functional teams and provides guidance on best practices for clinical supplies management
- Maintains required documents in a manner consistent with cGMP, 21 CFR Part 11, Annex 13 as well as internal QM, Corporate and Functional level SOPs
- Provide strategic leadership and mentor Study Managers and Study Engineers
- Work closely with the Studies Team and coordinate their inputs, ensure that assigned feasibility studies, are completed on time, per the proposed timeframes, within budget and to the required standards of quality
- Provides oversight and direction to project team members and study staff for study deliverables; including training as needed
10
Experience For Macs Study Manager Resume
- Undertake site visits to the Project location and areas for project sourcing
- Conduct infrastructure assessments and costing thereof, which includes tailings dams, power supply, accommodation, roads, water supply, etc
- Focus on securing follow-up work from the client
- Identify local and foreign suppliers and vendors
- Identify applicable local laws and rules
- Generate specifications for enquiries on mechanical equipment from the Process Department’s equipment lists
- Compile and/or coordinate compilation of bills of quantities
- Write up sections of the study documents and compile entire report
- Liaise and communicate with the client, as required
List of Typical Skills For a Study Manager Resume
1
Skills For Senior Study Manager Resume
- Good English language and communication skills, both verbal and written
- Excellent communication skills. Fluent in both Norwegian and English
- Extensive experience required in a lead discipline or project engineering experience in the engineering industry
- Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend
- Proven experience from management of subsea system deliveries as well as integration testing of complex subsea systems required
- Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements
- Strong understanding of Good Clinical Practices (GCP), federal regulations and international regulations (
2
Skills For Country Study Manager Resume
- Advanced MS Office skills (excel, word and power point)
- Management, supervisory and co-ordination skills
- Proven experience from study/FEED management and tender work required
- Manages the process of change effectively
- Experience in clinical trial operations with 3+ years’ experience in the management of complex oncology clinical trials
3
Skills For Global Study Manager Resume
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
- Working in early clinical operations pharmaceutical including direct monitoring and clinical trial/study management experience
- Delivery focussed with a strong client focus on actively building and maintaining customer and stakeholder relationships
- Good working knowledge of MS Project and/or Primavera planning system
- Conversant with the principles of capital and operating cost estimating Clear logical thinker, with the ability to make good decisions under pressure
- Good working knowledge of MS Project and / or Primavera planning system
4
Skills For Local Study Manager Resume
- Clinical development experience on the operational aspects of conducting clinical studies including
- Effective at problem solving and conflict resolution
- Experience working in a regulated environment (GLP, cGMP, CLIA)
- Experience coordinating with laboratory management to schedule projects as per the study protocol and study schedule
- Co-ordinate compilation of capital cost estimate, review and validates operating cost, co-ordinate input to financial model
- A strategic thinker with a wide range of knowledge and experience in the overall steps of the supply chain or process
- Strong knowledge of ICH-GCP regulations and the conduct of clinical studies
- Very good knowledge of GMP and GDP regulations
- Experiences in global project management
5
Skills For CTS Study Manager Resume
- Prioritise / balance multiple complex tasks and demands
- Good Clinical Practices (GCP), federal regulations and international regulations (International Harmonization Committee (ICH) regulations)
- Demonstrated leadership in project management and vendor management
- Effective written and verbal communication and a thorough knowledge of oral and written English
- Operator or industry experience from full field developments
6
Skills For IIT Study Manager Resume
- Extensive global clinical trial/study management experience
- BS/Nurse – with extensive relevant experience
- MS/PhD – with relevant experience
- Experience in the drug development or medical industry
- Experience with early phase clinical trials and/or oncology trials
7
Skills For Los Bronces Underground Study Manager Resume
- Clear logical thinker, with the ability to make good decisions under pressure
- Display strong leadership to ensure productive interactions between study team members and to provide seamless study delivery to the client
- Adapt and thrive in an environment with dynamic timelines and priorities
- Demonstrated oral and written communication and computer/database management
- Experience in the vaccine therapeutic areas
- Setting up study organization, interfacing with internal stakeholders, and establishing contact with suppliers when required
- Working in a leading company from healthcare sector
- Forecasting and tracking of the budget
8
Skills For Toxicology External Study Manager Resume
- Preparing technical materials and overseeing data collection
- Developing and monitoring a comprehensive quality assurance and control program
- Working with national, educational, and governmental contract laboratories in defining specimen requirements
- Assisting data managers in setting up result and QC file structures
- Documenting and monitoring study procedures and quality control
- Working with study collaborators to develop, implement and monitor study protocols
- Training medical technologists, phlebotomists, and other medical staff
- Assuring compliance with CLIA and OSHA regulations
- Tendering for new studies
9
Skills For Pre-study Manager Resume
- Conduct financial evaluations, including, grade, revenue TRA, general running costs of the mining fleet, plant operating costs
- An understanding of strategic thinking and change management and an ability to translate this understanding into appropriate action
- Provides consistent outstanding behaviour in relation to safety practices with a deep understanding of the importance of safety
- Gain and share knowledge regarding changing therapeutic areas
- Available and willing to travel for project related activities as required (e.g., Investigator Meeting attendance, etc.)
10
Skills For Macs Study Manager Resume
- Project Management: including implementation of risk management plans and management of complex study budgets and resourcing plans
- Provide project management oversight facilitating communication and focusing on key client deliverables through enhanced budget, risk, and milestone management
- Share knowledge related to oncology and early phase clinical trial conduct with Covance team members (includes mentoring, training, etc.)
- Be accountable for the implementation, monitoring and reporting of performance metrics
- Conduct infrastructure assessments and co-ordinate the costing thereof - includes tailing dams, power plants, accommodation, roads, water supply, etc
- Has full accountability for all assigned studies at Regional/country level (Global and local studies)including adherence to quality, timelines and budget
- Possibility of developing within the role and company’s structure
- Supportive and friendly working environment
List of Typical Responsibilities For a Study Manager Resume
1
Responsibilities For Senior Study Manager Resume
- Strong understanding of Good Clinical Practices (GCP), federal regulations and international
- Able to understand the impact of technology on studies and to use/develop computer skills while making appropriate use of GSK systems/software
- A good understanding of cGMP, GCP and ICH guidelines as related to IMP management
- Demonstrates high level of understanding of clinical research and clinical study management, and the associated regulatory, process and quality requirements
- Maintain good working relationships with clients and other consultants
2
Responsibilities For Country Study Manager Resume
- Solid understanding of local regulations, ICH-GCP guidelines and GSK written standards
- Working knowledge of ICH GCP and US Code of Federal Regulations applicable to the conduct of clinical trials (i.e., 21 CFR Parts 11, 50, 54, 56, 312 and 314)
- Preparing minutes and agendas; and supporting preparation of client deliverables
- Communicating with medical professionals and clients, and assisting with trainings, client meetings and national conferences
- Working with programmers to develop and test websites and online questionnaires
3
Responsibilities For Global Study Manager Resume
- Co-ordination , expertise and oversight in providing patient access to Roche Medicines Assistance initiatives
- Monitor budgets and facilitate budget management processes and issue resolution including logistical consultation and study design considerations
- Facilitate contracting process as required to ensure timely execution of work orders and change orders
- Provides operational insight during protocol design
- Liaise and co-ordinate with the internal Process, Engineering, and Projects groups to source the most suitable resources for studies
- Compile tender documents for issue to prospective suppliers and contractors
- Appoint consultants in areas where specific expertise is required
- Conduct risk analyses, as required
4
Responsibilities For Local Study Manager Resume
- Prepare and conduct a detailed hand over of a study to the Projects Department once awarded the execution of the project
- Assist in business development activities, as required
- Manages day-to-day activities of all aspects of clinical studies forassigned projects, including study plans, monitoring plans (as appropriate), timelines, resources, problem identification and resolution, status reports and budgets to ensure timely delivery of completed study deliverables
- Assists in the development of supported and sponsored studies, including the development of protocols, informed consent documents (as appropriate), case report forms (CRFs), and data collection and review
- In conjunction with procurement, coordinates the request for information and request for proposal processes, including site feasibility and qualification assessments
- Oversees the site approval, start-up, maintenance, and close-out processes with respect to contract review, critical document and reporting requirements and ICH/GCP, in conjunction with project team
5
Responsibilities For CTS Study Manager Resume
- Identifies and evaluates study and project issues, and issue escalation oversight; oversees all safety reporting, documentation and follow-up
- Represents Medical Affairs as the study subject matter expert in Lifecycle or external joint project team meetings
- Manages the development and implementation of improved processes for execution of internal and external studies within the Ventana Quality System
- Has full accountability and oversight of all assigned studies at regional/country level (global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans in the appropriate Roche planning system
- Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required
- Leads local studies’ teams, represents Country/Regional Clinical Operations at the global SMT, and provides Global teams with feedback from an affiliate perspective
- Plans and executes country study goals and commitments, and ensures compliance to relevant processes
- Coaches and provides support to responsible study team members
6
Responsibilities For IIT Study Manager Resume
- Provides study oversight, leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required
- Oversees study feasibility, site monitoring performance, preparation of risk based monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies
- Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of corrective and preventive actions for allocated studies
- Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Roche studies
- Participates in overall therapeutic area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc…) as required
- Manages and is responsible for all activities related to complex phase I and extended phase I/IIa clinical trials from the approved study concept to the clinical study report
- Develops and Leads a Study team, manages all Study Team activities as defined per SOPs/OIs and ensures the organization of regular Study Team meetings. Develops and manages budget, timelines and quality of the study and its deliverables
- Be responsible for forecasting and tracking of study costs
7
Responsibilities For Los Bronces Underground Study Manager Resume
- Ensure clinical trial registry and results posting according to global requirements and guidelines and manages the study insurance
- Responsible for training and oversight of CROs to ensure compliance with timelines
- Tracks and compiles patient enrollment, data cleaning progress and overall study progress and ensures study timelines are met
- Responsible for training and oversight of Clinical Research Organizations (CROs) to ensure compliance with timelines and budget
- Conducts lesson learned at any point in time when requested by management or any Study Team member and mandatory at study closure
- Manage and be responsible for all activities related to complex phase I and extended phase I/IIa clinical trials from the approved study concept to the clinical study report
8
Responsibilities For Toxicology External Study Manager Resume
- Work with OPL and ECL/CPL responsible for selection and oversight of External Suppliers (e.g. site management and monitoring CROs, Central Labs, central ECG reading center, etc.).he
- Writes protocols and amendments in collaboration with study team members and develops appropriate study related training for monitors and site personnel according to GCP and company standard
- Manages and be responsible for all activities related to complex phase I and extended phase I/IIa clinical trials from the approved study concept to the clinical study report
- Develop and Lead a Study team, manages all Study Team activities as defined per Standard Operating Procedures (SOPs)/Operating Information(OIs) and ensures the organization of regular Study Team meetings
- Develop and manage budget, timelines and quality of the study and its deliverables
- Be responsible for study specific feasibility and site selection to meet study enrollment and timelines
- Be responsible for timely delivery of all start up activities e.g. Chart Review Form (CRF) selection, CRF development, drug forecasting, study manuals, monitoring plan, data management plan, definition of end points, selection of safety and efficacy assessments, recruitment planning and oversight
9
Responsibilities For Pre-study Manager Resume
- Develop appropriate study related training for monitors and site personnel according to Global Clinical Program (GCP) and company standard
- Track and compile patient enrollment, data cleaning progress and overall study progress and ensure study timelines are met
- Ensure accurate data collection, protocol adherence, patient safety, Pharmacokinetic/Pharmacodynamics (PK/PD) biopsy sample integrity and GCP compliance
- Escalates severe deviations to a key parameter (i.e. recruitment, timelines, patient safety, protocol compliance, data collection/cleaning, budget) after discussing and in alignment with the Study Team to OPL and /or ECL/CPL and functional manager
- Act as a point of contact for managing/answering questions related to trial procedures and patients’ eligibility
- Contribute to the strategic management of the organisation
- Co-ordinate and provide the appropriate resources to designated task forces so that studies are completed on time, fit for purpose and according to budget and client requirements, and of high quality
- Contribute to the establishment, development and continuous improvement of systems and practices to enable studies and consulting services to be delivered more effectively and efficiently
- Pursue identified targets for studies and consulting services and subsequently market the company’s capability in order to win and secure work
10
Responsibilities For Macs Study Manager Resume
- Manage the process of preparation of designated study documents to ensure quality and accuracy of information
- Facilitate the contract review process
- Agree execution strategy with management, and ensure that studies are executed in alignment with Aker Solutions’ values and internal processes
- Supporting management of project deliverables (through all phases of study management) in accordance with overall project plans (eg. timelines, status reports, budget, data, resource, risk and quality)
- Study oversight, leadership and support to CRO staff, including feedback on CRO performance as required
- Processing and overseeing patient access requests for Roche Medicines via different mechanisms and pathways depending on registration and funding status of medicines
- Coordinates study/protocol training & investigator meetings
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