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 and includes, but is not limited to, 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, expertise and knowledge.
- 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 the day to day operational management activities of CROs, development of Key performance Indicators (KPIs), management of global resources, expertise, and knowledge within the CRO/vendor.
- 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, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
- 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 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, which may include leading sub-teams and/or acting as a liaison between groups.
- Provide a variance analysis of budget to actual and notifies finance of projected cost over/under expenditure.
- Ability to travel (no more than 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 gained with a CRO or Pharmaceutical Company working on later stage (Phase 2-4) multinational clinical studies. Experience in rare diseases and/or difficult to recruit patient populations preferred.
- 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, also strong reasoning and problem solving ability.
- Excellent communication (written and verbal) and presentation skills along with leadership qualities.
- Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
- Apply project management best practices to programs. Experience in novel clinical drug development.
- Experience with protocol, ICF, CRF, CSR development and review.
- Strong organizational skills and ability to deal with competing priorities.
Proficient with MS Office Suite (Excel, Word and 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. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.
Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We 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. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. 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.
