MedFocus Sr. Clin Ops Prog. Ldr 1524 in United States

POSITION OBJECTIVES:

  • You will provide operational expertise and strategic input to the development of Clinical Development Plans.

  • You will develop and lead the operational strategy on assigned programs in close collaboration with our strategic partner.

  • You will represent Clinical Operations on both the Global Program Team (GPT) and the Clinical Sub Team (CST).

  • You will provide sponsor’s oversight of our strategic partner, program-level direction and support to the clinical study manager(s) responsible for the execution of your studies.

POSITION ACCOUNTABILITIES:

  • Translate the Clinical Research Plan into an optimal operational plan

  • Plan and oversee the overall execution of the assigned clinical program(s) to meet necessary quality, budget and timelines,

  • Responsible for program budget planning and accountable for external spend related to program execution.

  • Communicate program status, cost and issues to ensure timely decision-making by senior management

  • Responsible for operational risk management strategy in collaboration with Strategic Partners

  • Review and provide expert clinical operations input into clinical documents such as Investigator Brochures,

  • Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports

  • Ensure adequate clinical operations resources are assigned to programs

  • Support functional strategic initiatives and process improvement

EDUCATION, EXPERIENCE, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s Degree or international equivalent required, Life Sciences preferred

  • Advanced degree is highly desirable.

  • Experience leading multiple late stage clinical trials

  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.

  • Demonstrated excellence in project/program management and matrix leadership

  • Fluent business English (oral and written)

  • 7+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management.

  • Experience must include Phase 2 and 3 studies and global/international studies or programs.

  • Experience in more than one therapeutic area

TRAVEL REQUIREMENTS:

  • Requires approximately 10-20 % travel, including overnight and international travel to other COMPANY sites, strategic partners, and therapeutic area required travel.

Please send resume to jobs@inventivhealth.com

Min Salary: $0.00

Max Salary: $0.00

State: MA