Clinical Trial Manager

Philadelphia, PA 19103

Posted: 07/17/2019 Industry: Other Area(s) Job Number: 6522

McGrath Systems is accepting applications for a Clinical Trial Manager to work in the Philadelphia, PA area.

 

Responsibilities:
  • 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.

Qualifications/Experience:
  • 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.

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