Education and Qualifications:
B.S. or M.S. and a minimum of two (2) years' relevant experience managing the clinical development of a compound in a pharmaceutical company or clinical research organization (CRO). Minimum of four (4) years of experience in an operations, management, or monitoring position in a CRO or pharmaceutical company or an equivalent combination of experience and education.
Thorough knowledge of clinical research and operations' practices and standards. Knowledge of the FDA drug development and approval processes. Knowledge of GCP regulations. Ability to manage Information and documents effectively; detail oriented. Ability to establish priorities and adapt to rapidly changing priorities. Excellent communication skills and willingness to work cooperatively in a team environment. Ability to interact in a positive manner with individuals outside of the company, including site personnel, vendors, and key opinion leaders (KOLs). Excellent command of the English language (spoken and written). Computer proficient. Ability to travel at least 20% of the time.
Responsibilities:
- Serves as a Study Lead for smaller clinical studies and/or as a co-lead for larger, global studies, ensuring studies are inspection ready at all times and be able to support assigned studies during inspections/audits.
- Ensures ongoing risk assessment, mitigation, and escalation for assigned
- Provides input on clinical study documents including but not limited to clinical trial protocols and clinical study
- Participates in scientific meetings and keeps up to date on current issues as they relate to assigned compound/studies.
- Interacts with Key Opinion Leaders (KOLs) on scientific and clinical issues related to assigned studies.
- Coordinates activities and provides oversight of external vendors providing services for clinical studies.
- Supports study request for proposal (RFP) process for potential CRO including bid review, selection, and contract
- Defines and ensures vendor deliverables are met, troubleshooting issues when
- Reviews and oversees vendor accruals and forecasting process, review invoices for
- Develops, writes and/or reviews clinical trial specific documents and plans including but not limited to clinical monitoring plans, essential document packets for IP release, informed consents, case report forms and study project
- Maintains sponsor oversight of the collection, review, maintenance, and tracking of regulatory documents for clinical study
- Maintains sponsor oversight of CROs including monitoring oversight visits, training, issue escalations and ensure protocol adherence, and ICH GCP requirements Provide input and oversight of TMF set-up and ensure overall accuracy and completeness of study Trial Master
- Tracks study timelines to ensure study is on track; escalate appropriately if issues
- Maintains study metrics and provides regular updates on study
- Ensures compliant with Gov requirements and that timely updates are made for assigned studies.