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Clinical Project Manager
4 months ago
Clinical Project Manager III
1 Year
Mettawa, IL (Remote ok)
Primary responsibilities include the following:
- Conduct Health Economics and Outcomes Research projects under the supervision of the manager to support the Value Proposition to Regulators, Payers, Patients, Prescribers, and Policy-makers.
- Provides HEOR strategic expertise under the supervision of the manager, to support clinical trial design and efficient implementation of HEOR-related contributions (e.g., COAs).
- Applies extensive technical knowledge and experience to plan, execute, and interpret research and data collection activities.
- Independently identifies appropriate internal and external data resources and external experts to execute strategies and research activities led by HEOR.
- Assures alignment of research activities with Scientific Research Annual Plan; communicates any changes from plan in timely manner.
- Actively participates in cross-functional meetings (e.g., Pipeline Commercialization Model teams, Global Brand Teams) as subject matter expert for tactical discussions and proactively escalates foreseeable challenges/issues back to manager in a timely manner. Must be able to influence activities in a matrix organization.
- Develops and maintains effective cross-functional working relationships to assure effective teamwork with assigned teams.
- Monitors scientific, regulatory and reimbursement/access trends, events and policies for their potential to affect current research responsibilities in order to provide advice/guidance on best course of action.
- Ability to write study protocols with a high scientific standard and able to defend the protocol methodologies at the HEOR Protocol Review Committee review meetings.
- Experience in drafting of study reports, creation of presentation materials from study reports, ability to present scientific research to non-scientific audiences.
Candidate Requirements:
- M.S. or Ph.D. in health economics, health services research, pharmaceutical sciences, or related discipline.
- Experience in conducting and reviewing prospective/retrospective observational studies; economic modeling studies; familiarity with COA/PRO development, validation research and clinical trial implementation.
- Experience with industry cross-collaboration amongst functions involved in product launches (medical affairs, commercial/marketing, market access, clinical development, regulatory, etc.).
- Minimum 5+ years of full-time pharmaceutical industry or consulting experience in HEOR required.
- Experience in immunology is a plus.