We are looking for a strategic, driven and results oriented Director of Clinical Operations (DCO) to join our growing team. In this role, you will have the opportunity to successfully lead and manage the execution of Flexion’s clinical studies from protocol inception through study closure.
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Provide strategic input and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality, and risk mitigation
Oversee the activities of direct reports on the Clinical Operations team
Lead the development of the overall clinical development plans
Lead the development of contingency/risk management plans for projects and assist the VP of Clinical Operations in the preparation and execution of sound development strategies.
Collaborate and ensure strong relationships with colleagues, outside consultants, and vendors to ensure successful completion of assigned clinical trials
Engage stakeholders in ongoing open dialogue that uncovers and mitigates challenges and leads to strengthening of the clinical team and its success
Oversee protocol development and ensures timely development of other core clinical trial documentation (e.g., investigator brochures, informed consent documents, case report forms, statistical analysis plans, monitoring plans, data management plans, etc)
Develop and manage the Clinical Operations outsourcing strategy including RFP generation, negotiation, capabilities assessment, and selection. Obtain buy-in and promote its success Oversee the day-to-day performance of CROs and other vendors
Drive data analysis, interpretation, and data representation for internal and external uses (e.g., presentations, abstracts, manuscripts)
Ensure compliance with SOPs, GCP and regulatory requirements for assigned clinical trials
Participate in Clinical Operations budgeting
Participate in the development and review of SOPs and Clinical Operations systems
Travel as necessary (~10%)
Requirements:
At least 10 years relevant clinical experience, with at least 5-8 years of clinical project management experience
Osteoarthritis or pain clinical study experience is preferred
Demonstrates extensive technical expertise in and understanding of cross-function clinical trials processes from study start-up through study closure (e.g., data management, safety, biostatistics, medical writing) with proficiency in clinical trial monitoring at a minimum
Strong experience in creating, driving and overseeing clinical operations strategy
Working, in-depth knowledge of industry standards including ICH guidelines, GCPs and the CFR
Demonstrated, effective project management skills
Ability to demonstrate a leadership role and drive quality progress
Ability to assess complex issues and identify creative, practical solutions
Demonstrated success in meeting project timelines and budgets
Demonstrated success in identifying, negotiating and overseeing outsourced clinical operations services and vendors
Demonstrated ability to work independently as well as in a team environment
Excellent communication, writing and presentation skills
International experience is a plus
Education:
Requires a BA/BS, BSN, or related degree.
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