Clinical Trial Oversight Lead

Clinical Trial Oversight Lead

Alnylam Pharmaceuticals

Multiple Locations

The Clinical Trial Oversight Lead oversees out sourced (or 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 Clinical Trial Oversight Lead will ensure that the CRO monitoring study sites is resulting in the effective identification and problem solving of issues. Findings and solutions will be communicated to both Alnylam and the CRO. The Clinical Trial Oversight Lead will also ensure that the CRO understands complex protocol processes and procedures and may support CRA protocol-specific training.

Summary of Key Responsibilities

  • Conduct oversight visits to assess site and CRO 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.
  • Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality.
  • Work both independently and collaboratively with cross-functional teams.
  • Create a database to document and track issues.
  • 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 and monitoring 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.
  • 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, e.g., implementation of complex protocol processes and procedures identified at high-performing sites.
  • Support inspection readiness and site preparation in the event of a regulatory authority audit in partnership with QA. Interface with regulatory inspectors, as needed.
  • Remain current with GCP and global regulatory requirements, have working knowledge of local/regional regulatory requirements.
  • Contribute to the overall development and improvement of company procedures, processes, and templates (e.g., study, laboratory, and pharmacy manuals) in support of continuous quality improvement.
  • Ability to travel 50-70%.

Qualifications

  • Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred.
  • 5+ years of relevant experience with 3+ years of direct monitoring xperience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred.
  • Proven experience in effectively communicating with site staff including and including KOLs and thought leaders.
  • Experience in all study phases and experience in rare medical conditions preferred.
  • Previous oversight and regulatory inspection experience preferred.
  • Comprehensive and current regulatory knowledge, including GCPs.
  • GCP or other training experience is a plus.
  • Demonstrates flexibility in schedule and willing to travel frequently in assigned region.
  • Fluency in multiple languages and cultural awareness is a plus.
  • Good 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).

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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