Clinical Project Scientist

RESPONSIBILITIES:

Clinical Project Scientist -  Cardiovascular Metabolism (CVM) Medical Affairs 

• The Clinical Project Scientist (CPS) is a key interface role in the CVM Medical Affairs (CVM MA) organization responsible for collaborating with therapeutic area teams to act as a liaison between therapeutic strategy and the clinical and operational implementation of product programs and clinical studies.
• The CPS plays a crucial role in ensuring that strategic level plans are executed in a timely, compliant, and within budget fashion in alignment with CVM MA goals.
• In addition, the role is critical in supporting all CVM MA activities including contracting, HCC requirements, SOP and process development, regulatory obligations etc. Scope of responsibility includes:

1. In concert with the Associate Director, Clinical Project Scientist, the contractor CPS will direct the overall coordination and management of CVM MA clinical studies including: working in a highly matrix organization, the contract CPS will play a key role in interfacing with our partners to contribute to concept and protocol development, drive accurate budget forecasting and communicate variances, provide project management across the study to drive metrics and alignment to timelines, facilitate critical path analyses and optimization/contingency planning, escalate issues as appropriate for timely resolution, provide updates to senior management as directed.

2. Provide input on the development of departmental processes to insure compliance to company and regulatory standards and procedures. Identify gaps and need for new process development. Participate in the development of training material for process roll-out as needed.

3. Facilitate coordination for management of data collection for PSUR, PADER, annual IND and other regulatory obligations for CVM MAF products.

4. Partner with Project Manager to insure timely and compliant contracting and HCC activities.

Education and Experience:

• BA/BS degree is required. 

• Advanced degree (MS, MBA) is desired.

• Strong leadership and collaboration skills are required.

• A minimum of 5 years working experience in clinical trial management within the pharmaceutical industry is required.

• Experience in Medical Affairs clinical trial management is highly desirable.

• A strong knowledge of clinical trial methodologies and ICH/GCP guidelines required.

• Financial planning and management experience required.

• Experience in leading cross functional teams in matrix environment is required.

• Strong interpersonal skills and ability to interact effectively with internal partners in a matrix setting are required.

• Ability to work in a fast-paced, dynamic environment is required.

• Strong communication skills required.

• Results/Performance driven.

• Ability to think creatively, critically, and proactively with strong problem solving skills is required.

• Therapeutic Area experience is desired.

 Sneha - 732 549 5307