Study Manager Job Description
Study manager
provides advice to Local Study Teams on AZ procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations.
Study Manager Duties & Responsibilities
To write an effective study manager job description, begin by listing detailed duties, responsibilities and expectations. We have included study manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Day to day management of assigned study director staff
Leadership of cross-functional teams with a heavy focus on metrics based results
Operational metric management and improvement
Provide coaching and guidance to staff in both technical execution and customer satisfaction and service
Progressive development and career pathing of assigned study director staff
Liaison with other support departments such as Quality Assurance, In Life Services, and Sample Preparation and Receipt to ensure a smooth process flow
Monitor and proactively manage IVT/Geno/Myco study operations metrics such as on time delivery and right the first time
Report on metrics at weekly management meetings
Develop expertise in applicable ISO, GLP, GMP, FDA guidance documents and their interpretation
Coordinate the development, and contribute to the writing and review of study related documents, including Study Concept Document and Protocol
Study Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Study Manager
List any licenses or certifications required by the position: PMP, GCP, ISD, ACRP, DABT, IVD, CE, GDPR, IVDR, AALAS
Education for Study Manager
Typically a job would require a certain level of education.
Employers hiring for the study manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Health, Healthcare, Life Sciences, Medical, Education, Life Science, Project Management, Management, Engineering
Skills for Study Manager
Desired skills for study manager include:
Monitoring
Good Clinical Practices
Clinical and regulatory operations
Project management tools
Sites
Spoken and written English
International guidelines ICH-GCP relevant local regulations
Drug safety requirements
Regulatory requirements
International standards
Desired experience for study manager includes:
Contribute to the writing and review of study related documentation, including safety and regulatory related documents, Clinical Study Report and publications
Work with the Clinical Study Planner (CSP) to develop/maintain study timelines
Participate in the ongoing evaluation of the feasibility of the clinical strategy and study timelines, amending the timelines as appropriate
Contribute to the selection of clinical investigators
Discuss study design with investigators/key opinion leaders (where relevant)
Organize and where appropriate, lead Investigator meetings
Study Manager Examples
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Study Manager Job Description
Job Description Example
Our company is searching for experienced candidates for the position of study manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for study manager
- Lead study teams
- Approve site initiation regulatory documents, approve site visit report and provide overall management of study related activities
- Manage Dose Level Review meetings, communicate and ensure decisions are effectively implemented
- Provide input into the development and approval (as required) of study-specific documents including (e)CRFs, SAP, DMP, DTP
- Contribute to the study level forecast of investigational product and support the creation of the study logistics plan
- Ensure that all study personnel understand the study timelines and deliverables
- Monitor the execution of the clinical study against the specified timelines, deliverables, and budget
- Communicate study status to management and update relevant systems
- Contribute to the review and interpretation of study results
- Oversee the identification, selection, set-up, and management of CROs and vendors, including approval of invoices
Qualifications for study manager
- Train and supervise direct reports and provide performance management/opportunities for career development and conduct performance reviews
- Bachelor’s degree in Biology, Nursing, or other Life Sciences or Health related field required
- Must be willing to travel at least 25% (possibly more)
- Advise UW Tacoma students on study abroad programming opportunities on all three UW campuses, including independent learning options
- Advise students on scholarship and fellowship opportunities for study abroad
- Develop, schedule, and implement information sessions on study abroad opportunities
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Study Manager Job Description
Job Description Example
Our company is searching for experienced candidates for the position of study manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for study manager
- Manage the study abroad portion of the OGA website
- Manage the Study Abroad Ambassadors (student workers), including evaluating their performance and developing professional development plans
- Maximize productivity and contribution of the local Study Start-up Team, through effective management of performance, communications and relations, the development and training of individual personnel
- Guarantee that every local Study Start-Up Specialist knows their area of responsibility and specific functions and identify future resource needs
- Identifies areas of best practice and contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function
- As requested by local Head of Clinical Operations and/or Therapeutic Area Leaders (TALs) and/or Country Medical Director participates in overall TA support in area(s) of expertise eg future landscaping activities, investigator/site development activities
- Leads local study teams, represents Country/Region Clinical Operation at the global SMT, and provides Global Teams with feedback from a local CCO perspective (Global Studies)
- Leads the local study team, including cross functional group leaders, and ensures GLORA process is followed (Local Studies), if apply
- Provides project management oversight
- Manages the implementation, on-time execution and conduct of clinical study(ies)
Qualifications for study manager
- Sound understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development
- Bachelor's degree plus three (3) years’ experience in international education, study abroad, or a related field
- Pro-active, detail-oriented self-starter with the ability to multi-task
- Demonstrated ability to work with students and/or colleagues from a variety of cultural, ethnic, educational, and economic backgrounds
- Ideally at least 4 years pharmaceutical industry experience with 4
- Experience in a monitor role or a role overseeing clinical trials desirable
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Study Manager Job Description
Job Description Example
Our growing company is hiring for a study manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for study manager
- Oversees the planning, monitoring and fiscal resources for Study Abroad Summer Institute programs
- Provides input on regulatory Documents
- Effectively communicates study progress and actively identifies issues that potentially impact evaluable study data, ethical study conduct and International Conference on Harmonization (ICH) compliance and identify potential interventions or solutions to manage the issues
- Help set the study strategy in alignment with the program strategy
- Reports into a director level and may have direct reports and responsibility for matrix managing their assigned study team(s)
- Develop appropriate site budget parameters and negotiating parameters
- Responsible for problem solving, risk mitigation, and contingency planning at study level
- 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
- Together with OPL and ECL/CPL responsible for selection and oversight of External Suppliers
- Project manager responsible for the overall execution of clinical trial(s) from study concept through study completion
Qualifications for study manager
- Experience in preclinical study design and experimentation
- Experience in a customer service based role, preferably in the medical device or biopharmaceutical industry
- Efficient and organized project management skills, strategic and critical thinking problem solving abilities
- Knowledge of GLP and other relevant FDA and ISO guidelines and regulations
- Early Phase trial experience strongly preferred
- A degree or equivalent in a scientific or health care discipline
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Study Manager Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of study manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for study manager
- Aware of both internal and external business environments, assess impact on clinical studies and make modifications as necessary
- Escalate performance issues to management with plans for resolution and ensure coordination/sharing of information within TA
- Manage the implementation, on-time execution and conduct of clinical study(ies) including the development of the Study Plan, key milestones, timelines, study costs, vendor selection and resource needs ensuring quality and compliance
- Provide input on regulatory documents (e.g., Investigator’s Brochure (IB), CSR, and the IND/DSUR)
- Effectively communicate study progress and actively identify issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues
- Coaches, and provides indirect line management support in partnership with the relevant line managers to Roche in-house study team members
- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, Pharma Business, GSM, functional management
- Effectively manages, develops, tracks project timelines of nonclinical outsourced studies
- Is operational lead in Pharmacology Sub Teams
- Facilitates open communication
Qualifications for study manager
- Must have strong knowledge of protocol and clinical drug development processes, clinical study design
- Strong knowledge of ICH/GCP guidelines
- Able to prioritize multiple tasks, plan proactively, and accomplish goals
- Must be self-motivated and adaptable to a dynamic environment
- Excellent computer skills in MS Word, PowerPoint, and Excel
- Oversee regional planning, management, and reporting of NASCR including ISS, Co‑operative group ISS, Research Partner Studies and EA
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Study Manager Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of study manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for study manager
- Provides support during regulatory inspections and internal functional group audits
- Full accountability for all assigned studies at Regional/country level (Global and local studies) including adherence to quality, timelines and budget
- Manages and is responsible for all activities related to clinical pharmacology, complex phase I, extended phase
- Manages the selection and oversight of External Suppliers
- Manages, tracks, and responsible for ensuring ongoing study activities, study execution and timelines are met
- Assesses and analyzes study information for variances and takes necessary actions within his/her responsibility to resolve variances
- Manages Contract Research Organizations (CROs) and External Suppliers
- Responsible for defining outsourced tasks, developing outsourcing plan, training and managing external suppliers to ensure compliance with timelines and budget
- Manages special programs and projects for Study Abroad
- Works with International partners to identify and set up course materials
Qualifications for study manager
- Experience in leadership and/or management of others
- Oversee regional cross-functional NASCR activities, identifying and resolving issues for global standardisation
- Partner with NASCR Director and counterpart Sr
- Act as regional subject matter expert in global process standardisation and process improvement initiatives
- Oversee/facilitate resolution of cross-functional study specific issues
- Establish and maintain global cross-functional business relationships