Clinical Program Manager (EU MDR)

Clinical Program Manager (EU MDR)
  • Competitive
    HOUR
  • Permanent
  • Vista CA, US Vista SAN DIEGO US 92081
Job Ref: JO000126507
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 10 January 2022


Sr. Clinical Program Manager

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 Sr. Clinical Program Manager role is critical as this position will assume project management responsibilities for assigned studies and will be responsible and accountable for the timely completion of deliverables related to EU MDR Inspection Readiness. The Program Manager will oversee, design, plan and develop clinical evaluation research studies (protocol, informed consent, case report forms, training, etc.) in compliance with regulatory requirements, standard operating procedures (SOP), and alignment with study objectives.

The Role

  • Assists with the design and drafting of clinical trial protocols in accordance with the needs of the EU MDR and other research programs.
  • Oversight of all aspects of assigned clinical protocols in accordance with SOPs, GCP and other relevant regulations.
  • In conjunction with their study team, oversees the vetting, onboarding and general oversight of clinical trial sites.
  • Interfaces with study investigators and site personnel to ensure patient safety and data quality.
  • Oversees study support staff such as clinical research associates (i.e., monitors), data management, statistical, contract, and finance personnel to ensure efficient execution of the trial.
  • Provides study updates to cross-functional team members at routine and ad-hoc meetings.
  • Oversees drafting of clinical trial documents such as ICFs, CRFs, monitoring plans, study logs, etc.
  • Oversees the maintenance of study-related platforms such as the eTMF, EDC, CDMS, etc.
  • Drafts initial study budgets and, in concert with the finance team member, oversees and reports significant variances in the study budget.
  • Supports Clinical Affairs during onsite audits and inspections
  • Assists cross-functional team members in drafting documents which become part of regulatory submissions
  • In conjunction with the rest of the Clinical Affairs team, drafts and maintains SOPs relevant to the Clinical Affairs department.
  • Support product launch activities, as needed
  • Understanding of competitive landscapes for assigned products
  • Represents Clinical Affairs during strategic meetings for company products with an understanding of competitive landscape
  • Exhibit strong technical writing ability to clearly and effectively communicate technical ideas and concepts.

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.

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SRGTalent
31/01/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Johnny Hill

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