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Clinical Trial Manager - CTM (Science & Biotech)
Philadelphia, PA 19103
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Jun 22, 2019
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Job Description

Our client, a start up pharmaceutical company, is currently expanding their team! An exciting opportunity to join a small pharmaceutical company and grow along with them! CNS experience is a plus... this position is located in the company headquarters in Philadelphia, PA.

Clinical Trial Manager
The Clinical Trial Manager will direct and coordinate the operational and logistical activities necessary for the initiation and completion of clinical trials on time and on budget
Primary Responsibilities:
• Responsible for managing activities associated with the conduct of assigned clinical trials.
• Develop and assist with protocols, consent forms, monitoring plans, case report forms, and other clinical documents related to clinical trials.
• Manage investigational sites and/or CROs to ensure compliance with protocol and overall clinical objectives; including traveling to sites to conduct pre-study, initiation, interim and closeout visits and/or co-monitor with CRO or contract associates.
• Negotiate contracts and budgets with clinical investigational sites and other vendors.
• Supervise clinical site monitors (internal and/or contract).
• Select and manage CROs and other consultants and vendors to ensure adherence to domestic and international regulations and standards (GCP and ICH).
• Participate in the review and update of existing procedures and develop new procedures as needed.
• Develop and maintain clinical project timelines.
• Interface with other departments within the organization to exchange technical data and negotiate courses of action on behalf of Clinical Operations.
• Lead study team meetings and update project management on a weekly basis of study timelines and activities.
• Perform other related duties as required to support Clinical Operations
Qualifications/Requirements/Skills:
• BS or equivalent experience in a scientific or medical discipline with 5 -10 years clinical trials management experience.
• Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors)
• Previous management or project management experience with demonstrated leadership ability.
• Excellent communication; interpersonal skills and influencing skills
• Ability to determine the people, funding, materials and support to meet project goals and timelines.
• Previous budget and contract negotiation experience.
• Knowledge of GCP .
• Ability to pro-actively identify and solve problems that threaten timelines and successful completion of clinical trials.
• Able to work independently.
• Excellent time management skills (timelines, schedules, task prioritization).
• Willing and able to travel up to 30% of time.