Clinical Program Manager (IIS)

Clinical Program Manager (IIS)
  • $100 per Hour
  • Temporary to Hire
  • Vista CA, US Vista SAN DIEGO US 92081
Job Ref: JO000127401
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 07 January 2022

Clinical Program Manager (IIS)

At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.

Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The Clinical Program Manager (IIS) is thought leader the Clinical Affairs department who oversees the company’s Research Grant (Investigator-Initiated Study) program. Additionally, this position will be involved in the design, oversight and execution real-world evidence (RWE) research programs to satisfy the data generation needs. The ideal candidate is a highly organized individual who demonstrates superior communication skills (written and oral), individual initiative, and problem-solving capabilities. This person should be able to understand complex issues related to bringing medical devices to the market and be able to identify opportunities for initiatives that will benefit the department and company. Due to the nature of this role and interactions with key physicians, the individual will have a high level of professionalism and discretion.

Here’s What You’ll Do:

  • Oversight of the Investigator Initiated Study (IIS) program from grant submission to deliverable execution
  • Manages the IIS contracting process between investigators and legal associates Sets cross-functional grant proposal review meetings and provides post-approval status updates
  • Ensures IIS program spend is within budget and works with physicians to ensure deliverables are met on time. Develops RWE programs alone or in partnership with external research firms and/or contract research organizations.
  • Oversees and contributes design of any RWE protocols.
  • Drafts initial study budgets and, in concert with the finance team member, oversees and reports significant variances in the study budget.
  • Supports the EU MDR evidence generation program with production and/or analysis of data.
  • Represents Clinical Affairs during strategic meetings for company products with an understanding of competitive landscape
  • Supports Clinical Affairs during onsite audits and inspections
  • Assists cross-functional team members in drafting documents which become part of regulatory submissions

Here’s What You’ll Bring to the Table:

  • Bachelor's degree in a science-related field and eight (8) years of research experience with a focus, at least in part, on epidemiologic studies, surveys or other non-traditional evidence generating research programs or an equivalent combination of experience, education, and training.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#LI-Remote #LI-SH1

31/01/2022 12:00:00
USD 0.00 100.00 Hour
Contact Consultant:
Shari Hulitt

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