Senior Clinical Operations Manager
3 settimane fa
Job Title: Senior Clinical Operations Manager
Job Summary:
We are seeking a highly skilled Senior Clinical Operations Manager to lead and manage aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development programs. The ideal candidate will have a strong background in clinical research and operations, with experience in managing global clinical studies, leading cross-functional teams, and developing contingency/risk management plans.
- Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise, and knowledge.
- Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
- Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs.
- Develop and manage global resources, expertise, and knowledge within the CRO/vendor.
- Lead the development of contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies.
- 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, Medical Affairs.
Requirements:
- Bachelor's Degree required, advanced degree in a scientific and/or business/finance discipline 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, also strong reasoning and problem-solving ability.
- Excellent communication (written and verbal) and presentation skills along with leadership qualities.
About Alnylam:
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.
We are a people-first culture guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people.
We are an equal employment opportunity employer and are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential.
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.
We are committed to an inclusive recruitment process and equal employment opportunity.
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