Job Listing: Clinical Protocol Manager

Our client, the worlds largest pharmaceutical company, is looking for a Clinical Protocol Manager to join their team for a 1 year contract.

The Clinical Protocol Manager will be responsible for the delivery of multiple clinical studies from synopsis development through reporting, submission and as needed regulatory defense activities within a program in alignment with the overall program timeline, to cost and quality goals through the matrix leadership of the Study Team(s). Duties include but are not limited to the following:
- Manage study deliverables through internal and external resources and is the primary point of contact and interface between these functional groups, vendors and FSPs
- Partner with the Project Planner and Project Manager to ensure accurate schedule, cost, resource management and controls are established and maintained between clinical study activities and the development plan
- Active contributor to protocol development via participation in protocol design meetings to ensure operational consequences are factored into design decisions and appropriately represented when synopsis is signed off / endorsed
- Responsible for ensuring clinical study risks are identified and communicated to the Clinician and Project Manager for integration into the program level risk management plan along with appropriate contingencies.
- Responsible for requesting resources through relevant CoEs to build study team and ensure adequate resources applied. Monitor resource requirements on an ongoing basis in partnership with CoEs, Vendors and FSPs to maximize efficiency and productivity.

To be QUALIFIED for the Clinical Protocol Manager, individuals MUST have the following qualifications:
- At least 5 years clinical operations and pharmaceutical business experience
- Leadership, project management, resource management, administrative and technical capabilities
- Effective verbal and written communication skills
- Knowledge of team development principles and successful implementation
- Experience supporting regulatory submissions highly desired

Required Skills for Clinical Protocol Manager Job:

  • DRUG DEVELOPMENT
  • CLINICAL STUDY MGMT.
  • DATA MANAGEMENT
  • REGULATORY PROCESS
  • BUDGET MGMT.
  • VENDOR MGMT.
  • About Aerotek Scientific:

    Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.

    Required Skills

    Date Posted: July 18, 2008

    Job Details

    Job Location

    Candidate Application

    Employer: Aerotek Scientific Address: 538 Preston Ave. Contact: Crysta Lemon
    Job Type: Full-time City: New London
    Experience:Any State: Connecticut E-mail: clemon@aerotek.com
    Education: Any Zip Code:06320 Online: Website Link

    Salary and Benefits

    Rate: Based on experience.

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