Evidence Generation/RWE Project Manager (EPM)

Description

The Evidence Generation/RWE Project Manager (EPM) is responsible for the management of all aspects of evidence generation activities for assigned project(s). The EPM, in collaboration with the Medical Science Directors, Scientific advisors, Market Access Leads and Managers of his therapeutic area, is accountable for achieving successful delivery of evidence generation and real-world evidence (RWE) activities at the project level by meeting company and regulatory requirements according to time, quality/Product and budget constraints. To join our growing Evidence Generation Centre operations team.

Key Responsibilities

• Proactively lead project level operational aspects of Study Management Team (SMT) including management of study timeline, budget, resources, and vendors.
• Provide efficient updates on trial progress to the evidence generation operation lead with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
• Lead study startup process, including but not limited to project internal approvals, protocol development, review and approval, vendor (or data custodian) selection, qualification, and a contracting, conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), filing and archiving the study documents and managing budgets.
• Ensure effective project plans are in place and operational for each study and work proactively with the Study Management Team (SMT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.

Qualifications

Education:

• Bachelor’s degree in Life Sciences, Nursing Licensure, Pharmacy, or related scientific field (or equivalent experience) is required.
• Preferably a master’s degree or higher

Experience and Skills:

Required:

• Three or more years clinical operations experience; with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.
• Five or more years of clinical project management experience at a sponsor or CRO company is preferred for EPM
• Experience in the design, classification and execution of observational research studies is preferred.

Preferred: Therapeutic experience in oncology and/or Immunology

Notes from Manager:

• Looking for someone with experience in running Real World Evidence(RWE) studies.
• Clinical trial experience good to have but RWE preferred
• Experience with clinical trial operations valuable
• Multitasking essential
• Handle multitude of research projects (10-20)
• 3 days a week in office (flexible Mon-Thurs)
• Working hours flexible (10-2 core; 7-3/8-4/9-5)
• Need min of 2 years PM exp over clinical experience
• Therapeutical experience in oncology or immunology preferred