Job Description - Clinical Trial Manager (240045)
Overview
The Clinical Trial Manager is responsible for aspects of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program timelines and budget. Responsibilities include preparation of study-related materials, relationship management between study sites and vendors (in particular CROs), supervision of study-related activities, identification of project risks, and contingency planning.
Key Responsibilities
Lead and manage integration of all project team activities, leveraging internal and development partner resources, expertise, and knowledge, along with optimizing CRO resources.
Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
Provide leadership and input into global subject/patient recruitment plans.
Effectively communicate and interact with Key Opinion Leaders.
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, budgetary and financial information, and performance metrics.
Participate in Case Report Form design and 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.
Prepare budgets, timelines, and forecasts for clinical studies.
Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, Medical Affairs.
Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
Ability to travel (no more than an annual average of 20%).
Qualifications
Bachelor's Degree is required; an advanced degree in a scientific and/or business/finance discipline is preferred.
3+ years of clinical research experience with a CRO or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies.
1-3+ 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 a fast-paced CRO outsourced environment.
Experience with protocol, ICF, CRF, CSR development and review.
Proficient with MS Office Suite (Excel, Word, PowerPoint) and MS Project.
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. Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people.
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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