Clinical Operations Director
il y a 2 semaines
Alnylam Pharmaceuticals Inc. is seeking a highly skilled Clinical Operations Manager to join our team. As a key member of our clinical operations department, you will be responsible for leading and managing the integration of all project team activities, leveraging internal and development partner resources, expertise, and knowledge, along with optimizing CRO resources.
Key Responsibilities:- Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
- Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise, and knowledge, along with optimizing CRO resources.
- Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and day-to-day operational management activities of CROs.
- Manage strategic study operations including study sites and tracking systems for regulatory submissions, CRO KPIs, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, and budgetary information.
- Participate in Case Report Form design, user acceptance testing in partnership with data management.
- Generate country-specific Informed Consent Form(s).
- Lead the development of contingency/risk management plans for projects.
- Provide support to clinical trial managers within and/or across programs.
- Budgets, timelines, and forecasts preparation for clinical studies.
- Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, and Medical Affairs.
- Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
- Bachelor's Degree is required. An advanced degree in a scientific and/or business/finance discipline is preferred.
- 5+ years of clinical research experience gained with a CRO or Pharmaceutical Company working on later-stage (Phase 2-4) multinational clinical studies.
- 2-4+ years clinical project management experience with global clinical studies.
- Strong regulatory knowledge, including Good Clinical Practices (GCPs).
- Exceptional organizational skills and ability to deal with competing priorities.
- Excellent communication (written and verbal) and presentation skills along with leadership qualities.
- Knowledge of global clinical trial management in fast-paced CRO outsourced environment.
- Apply project management best practices to programs.
- Experience with protocol, ICF, CRF, CSR development and review.
- Proficient with MS Office Suite (Excel, Word, and PowerPoint) and MS Project.
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality. Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.
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