Associate Director, Clinical Trial Oversight / Houten

Organisatie: Alnylam Pharmaceuticals
Locatie: Houten
Functie: Associate Director, Clinical Trial Oversight
Vervaldatum: 13/05/2021
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Alnylam is the world’s leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work six years in a row (2015-2020), a Great Place to Work in the and Switzerland two years in a row (2019-2020) and a Science Magazine’s Top Employer two years in a row (2019-2020). Please visit for more information.

Reporting into the Senior Director, the Associate Director Clinical Trial Oversight oversees a team of Alnylam Clinical Trial Oversight Leads (CTOLs), participates in the oversight of the Oversight Functional Service Provider (FSP), and may serve as an Oversight Program Manager for assigned studies. The Alnylam Oversight team and FSP Oversight Team partner with the Alnylam Clinical Operations study teams to oversee Site compliance and field-based( CRO) monitoring activities to ensure the quality execution of protocol procedures, adherence to good clinical practices (GCP) and evolving regulatory requirements, and ensure consistency of monitoring activities. Alnylam programs span the globe, often entailing complex protocol procedures and specialty tests, and focus on rare diseases for which access to applicable patient populations may require the involvement of clinical trial sites with limited research experience. The Associate Director Clinical Trial Oversight will provide effective leadership to the oversight team members so they can, in turn, ensure that the CRO monitoring of study sites is resulting in the effective identification and problem solving of issues, and during the conduct of an Oversight Visit, ensure that the CRA and FSP Clinical Oversight Leads (COLs) understand complex protocol processes and procedures and may support CRA and COL protocol-specific training.

Summary of Key Responsibilities

  • Lead, develop, and manage global CTOLs staff
  • Help to create vision and operating model for growing functional area within the Clinical Operations organization
  • Develop process for CTOL team members to remain current with GCP and global regulatory requirements, have working knowledge of local/regional regulatory requirements
  • Oversee FSP Team and active participation in Governance and Joint Operational Committees
  • Interview FSP Oversight COL candidates and Conduct Oversight Visit for FSP Oversight COLs
  • Serve as Oversight Program Manager (PM), as assigned: Perform Oversight Program management duties in accordance to the Oversight Plan of Assigned study(s) If applicable to assigned PM duties, conduct Oversight Meetings to include scheduling of calls, agenda/meeting minutes, trend and open issues tracker development and management Manages activities of assigned CTOL/COL staff specific including visit assignment, oversight report review, tracking of oversight visits schedules Conducts Oversight Visits of FSP COLs
  • Ability to travel up to 50% – Regional and Global travel is required
  • Provide coaching, guidance and mentorship to CTOL/COL teams for following duties and may also be responsible for performing same duties, as needed: Conduct oversight visits to assess Site, CRO, and COL performance as required. Provide assessment of the completeness and accuracy of site monitoring activities undertaken by CRO personnel. Escalate and support corrective actions as required. Evaluate clinical trial sites and ensure site procedures are performed in accordance with the study protocol, applicable study manuals, GCP, and local regulatory requirements Provide assessment of completeness and accuracy of oversight activities of the COL and escalate and support corrective actions as required Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality. Develop tools and approaches for this new team to work within an Alnylam office location or regionally; able to succeed both independently and collaboratively with cross-functional teams Document and track issues identified during oversight activities. Participate in, or review reports from, site qualification and initiation visits, as applicable. Communicate important clinical site assessment information to Clinical sub-team May participate in centralized data review to identify sites requiring oversight visits Partner with Alnylam Clinical Operations and Research staff to become knowledgeable on protocol procedures and requirements Ad hoc participant in Clinical sub-team meetings and other internal meetings as applicable May assist or lead study-related training of CRO personnel, particularly CRAs, and study site team members as well as present at Investigator Meetings Partner with Alnylam and CRO study team members to provide on-site support, answer site questions, and develop custom solutions as needed Provide insight to Alnylam and CRO study team on best practices, implementation of complex protocol processes and procedures identified at high-performing sites Contribute to the overall development and improvement of company procedures, processes, and templates study, laboratory, and pharmacy manuals) in support of continuous quality improvement Guide teams on inspection readiness and site preparation in the event of a regulatory authority audit in partnership with QA. Interface with regulatory inspectors, as needed
  • Qualifications

  • Bachelor’s Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred
  • Previous experience in Oversight, Oversight Line Management preferred
  • Proven experience in effectively leading teams and regionally based staff
  • Solid direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/CRA management experience preferred
  • Experience in all study phases of clinical research (Phase I-IV) and experience in rare medical conditions preferred.
  • Previous oversight and regulatory inspection experience preferred.
  • Comprehensive and current regulatory knowledge, including GCPs
  •  Along with the Clinical Operations Lead, ability to build and maintain relationships with Key Opinion Leaders and their study teams site staff
  • Demonstrates flexibility in schedule and willing to travel frequently
  • Fluency in multiple languages and cultural awareness is a plus
  • Excellent leadership and organizational skills and ability to deal with competing priorities
  • Effective communication skills (written, verbal and presentation)
  • Creative thinker, curious and unafraid to ask questions
  • Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
  • Proficient with MS Office Suite (Excel, Word and PowerPoint).
  • Categorieën: Vacatures
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