Position: Clinical Study Manager
Reporting: Executive Director, Clinical Development and Operations
This position will support the implementation of assigned clinical trials for company. The Clinical Study Manager will have hands-on responsibility and strategic oversight on the planning and execution of clinical activities related to the clinical study centers/regions under his/her responsibility.
Responsibilities may include operational management of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and other vendors.
- Key contributor to the Clinical Operations team responsible for the planning and execution of assigned clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, in line with corporate goals for approval of products.
- Participate in the selection of CROs and other vendors to support clinical study operations centers.
- Oversee required country regulatory (e.g. FDA, MoH) and country/site IRB/IEC approvals/notifications.
- Oversee clinical monitoring quality and adherence to established processes and plans.
- Manage the budget and resources allocated to the assigned clinical development activities.
- Establish productive, interactive relationships with key internal departments
- Manage consultants and collaborators under their responsibility.
- Lead/support the cross-functional global team for execution of the study and be the primary operational contact for the study.
- Liaise with and provide information to regulatory affairs as required.
- Liaise with the pharmaceutical development team to ensure proper planning and distribution of clinical trial supplies.
- Support/provide input into the writing of protocols, protocol amendments, informed consents, clinical study reports, initial IND and annual IND updates, investigators brochure and updates, etc.
- Provide operational and strategic input into study documents and/or lead development of these documents such as the Monitoring Plan, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
- Inform team members and leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation.
- Participate in the development of SOPs, facilitate training and ensure compliance for the team under his/her supervision.
- Additional duties and responsibilities that may be assigned from time to time.
- Minimum Bachelor’s Degree in Science Discipline (Healthcare Degree Preferred)
- 4+ years of current pharma / biotech experience, including Clinical Development and/or Clinical Operations with a minimum of 2 years clinical study management experience
- Experience considered relevant includes clinical research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred, Clinical study management skills are required. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
- Relevant Therapeutic Area Experience such as infectious diseases is highly desirable (e.g., invasive fungal infections). Other therapeutic area experiences are also considered.
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Vendor management experience
- Assume co-monitoring (visit the site with the CRO CRA or inhouse CRA) responsibilities as needed.
- Project and vendor management, analytical and problem-solving skills
- Effective verbal and written communication and interpersonal skills
- Ability to quickly adapt to and manage an environment with rapidly changing organizational needs
- Ability to travel domestically up to 20% if needed. Occasional international travel may be required to participate in investigator meetings, SIVs, or conferences.
- Management of Phase 1, 2 and/or 3 trials
- Onsite monitoring experience
- Managment of CRO study execution
- Global clinical trial management