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Program Manager, Clinical Operations, Pharmaceuticals

Company: GForce Life Sciences
Location: Cambridge
Posted on: January 17, 2020

Job Description:

Program Manager, Clinical Operations, Pharmaceuticals - - Objectives: Provide operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for one or more clinical programs. Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors. Provide program-level sponsor's operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget. Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) accountable for the development and execution of the CDP. Accountabilities: Accountable to the GPT for the translation of the CDP into an optimal operational strategy and plan. Ensures assessment of various operational scenarios for optimal execution of the CDP. Partners with the CST to develop high-quality study synopsis/protocol by providing operational input and by ensuring all relevant stakeholders (both internal and external) are involved and contributing. Collaborate with early or late phase COPL counterpart to ensure alignment and seamless interactions with the GPT. Maintain close communication with the Global Program Leader to ensure expectations and activities are aligned. Develop and lead the early or late phase clinical program operational strategy and planning on assigned clinical programs in close collaboration with the Clinical Operations Managers (COMs), our strategic partners/other CROs, other vendors, and with the CST. Perform program-level oversight of our strategic partners and other vendors to ensure the overall operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Collaborate with COMs and cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners/other CROs/other vendors, including escalation of issues to governance committees and to senior management when warranted. Responsible for clinical program budget planning and accountable for external spend related to clinical program execution. Works closely with COMs, Global Program Management (GPM), Outsourcing Management, and Finance to ensure on a regular basis that budgets, enrolment, and gaiting are accurate. Communicates program status, cost and issues to ensure timely decision-making by senior management. Provide program-level direction, guidance and support to the COM in development of study strategy operational plans including enrolment models and risk management strategy. Serve as the point of escalation for the COMs for issues that can't be resolved at the study level. May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence. Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis & protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate. Collaborate with COMs, Strategic Partners/other CROs/other vendors to ensure inspection readiness. Leads Clinical Operations aspects of inspection readiness activities, and acts as subject matter expert during regulatory inspections Education: Bachelor's Degree or international equivalent required, Life Sciences preferred. Experience: 8+ years' experience in pharmaceutical industry and/or clinical research organization, including 5+ years clinical study/project management. Experience must include early phase clinical studies/Phase 2 studies or later phase global/international studies or programs. Experience in more than one therapeutic area is highly desired. Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Term & Start: Start ASAP 12 + month contract Must be in Cambridge, MA or willing to relocate. -

Keywords: GForce Life Sciences, Boston , Program Manager, Clinical Operations, Pharmaceuticals, Healthcare , Cambridge, Massachusetts

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