Clinical Trial Manager
123 Main Street Philadelphia, PA 19103
McGrath Systems is accepting applications for a Clinical Trial Manager to work in the Philadelphia, PA area.
- Conducts and/or oversees all aspects required for selecting, initiating, monitoring and closing sites in accordance with all applicable SOPs and GCP/ICH requirements.
- Serves as a primary contact for internal clinical monitoring study team members, external vendors and clinical sites.
- Leads weekly conference calls
- Manages and executes project management (maintains integrated timelines with all discipline deliverables), monitoring, site management, trial master files, and clinical research associate performance.
- Assists in the preparation of clinical trial documents, including study protocols, amendments, model ICFs, laboratory manuals, CRF completion guidelines, study specific instructions, etc.
- Provides timely and accurate information to Management for project level tracking.
- Participates in evaluating investigational drug (IP) supply requirements and manages the logistical aspects of distributing supplies to the investigational sites.
- Coordinates investigator meetings and develops presentation materials.
- Conducts weekly team (interdisciplinary) meetings.
- Manages CRAs and CTAs
- Routinely reviews study data and progress of EDC entry; works with data management and clinical sites to resolve data discrepancies. This includes reviewing primary, secondary and safety endpoints for inconsistency, irregularities, and/or signals.
- Identifies program/clinical trial risks; proactively suggests and implements mitigation strategies.
- Participates in the management of vendors to get deliverables delivered on-time and on-budget.
- Participates in the preparation and finalization of company SOPs as necessary.
- Performs job duties with minimal supervision and has a sound critical thinking and problem-solving skills.
- Bachelor’ s degree required
- 4-6 years pharmaceutical industry clinical trial management experience, phase 1-3 trials
- Experience with CNS clinical trials preferred
- Travel requirements: variable: ~35%
McGrath Systems is an Equal Opportunity Employer and embraces diversity in the workplace.