Manager, R&D Contract Management


Cambridge, MA

Industry: Biotech/Pharma


5 - 7 years

Posted 98 days ago

  by    Jitendra Kushwah

This position is responsible for the management of Investigator Sponsored Studies (ISS) for assigned drug programs globally.

The role includes managing the Scientific Research Committee (SRC) meetings for the purpose of reviewing and approving ISS protocols submitted by external parties.

Working independently, the Sr. Project Manager is responsible for overseeing the timely execution of contracts and financial payments, budgeting and financialforecasting in finance systems, tracking ISS study progression, managing the ISS database, and for maintaining ongoing metrics and reports on a regular basis. This position liaises with the Medical Director responsible for the drug program and with various other members of the Scientific Review Committee (SRC), internal finance teams, legal representatives, and with ISS contacts around the world.


Responsibilities include:

·        Ability to manage all aspects of SRC meetings: Prepare the agenda, distribute meeting materials, manage presenters, raise pertinent questions

·        Proactively manage ISSs through the approval and contract negotiation stages

·        Metrics reporting: prepare and track ISS cycle times and make recommendations for process changes

·        Working with Regulatory to generate cross reference letters and ensure all regulatory documents for studies are in place

·        Working with Legal to generate contracts and CDAs

·        Forecasting study drug requirements to CPRS group and arranging for shipping and monitoring of study drug supply

·        Expertise in forecasting milestone payments

·        Corresponding with sites to provide updates on ISS status pre-approval

·        Maintain communications with Pharmacovigilance for drug safety updates and distribute formal update letters to investigator sites as needed

·        Distributing Investigator Brochures (IBs)

·        Communicating with GMO senior management, Medical Directors, global colleagues and MSL team regarding study updates

·        Preparing Purchase Orders (POs) and managing invoices

·        Training of SRC members on VisionTracker (database software)

·        Ability to write ISS quality documents and mentor colleagues on ISS processes

·        Ensure ISS records and history are audit ready

·        Responsible for maintaining an efficient, compliant global ISS process that includes a continuous improvement plan


Minimum Qualifications:

·        BachelorDegree in business or science area with 4+ years pharma/biotech industry experience in clinical research or medical affairs or if no degree, a minimum of 6 years work history in pharmaceutical/biotech industry working in clinical research or medical affairs

·        Track record of successfully managing multiple complex projects from start to completion

·        Ability to work independently without supervision


Other required skills and attributes:

·        Experience in managing budgets and forecasts

·        Demonstrated superb organizational, time management and communication skills (verbal and written)

·        Demonstrated experience working on multiple projects simultaneously

·        Strong interpersonal skills with the ability to interact with all levels of the organization

$130K - $150K