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Associate Director Data Operations

2 months ago

Bedford, Bedford, United Kingdom Progenics Pharmaceutical Inc Full time
Job Title: Associate Director Data Operations

Lantheus is a leading pharmaceutical company that is committed to delivering innovative solutions for patients with cancer and other serious diseases. We are seeking an experienced Associate Director Data Operations to join our team.

Job Summary:

The Associate Director Data Operations will lead the planning, execution, and conduct of complex clinical programs while adhering to budget, scope, and timelines. This role will be responsible for managing all aspects of multiple clinical trials, including CRO, vendor, and internal team management to drive a high-functioning and results-driven team.

Key Responsibilities:
  • Establish and continuously monitor/update global study timelines and budgets, including all internal functional areas, vendors, CROs, and promptly escalating significant risks or changes
  • Serve as primary Operations contact for internal and external study team members on assigned studies/projects and as the escalation point for investigators and sites
  • Oversee CRO and/or vendor activities and coordinate cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to site selection, study start-up, recruitment, study conduct, and database lock and study close-out
  • Contribute to development of plans and documents led by other functions such as data management and data review plans, statistical analysis plan, safety management plan, etc.
  • Track and report on the overall status of assigned clinical trials including enrollment metrics, key performance indicators (e.g., deviations, trial risks, monitoring metrics), milestones, timelines, and budgets
  • Continuously assess risks to study performance, timelines, budgets, and proactively plan risk mitigation strategies
  • Review and/or directly contribute to study documents such as vendor specifications, study manuals, training materials, site and patient-facing materials, CRFs, monitoring reports, special correspondence, communication plans, etc.
  • Contribute to protocols, clinical study reports, annual reports, key safety reports, and regulatory documents
  • Lead quality reviews of study conduct, including TMF and monitoring report reviews, and lead inspection readiness activities for both internal sponsor audits and health agency audits (FDA, Health Canada, etc)
  • Perform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performance
  • Direct or indirect management and oversight of CTA and/or junior COLs
  • Contribute to management decisions on project team resourcing needs and strategy
Requirements:
  • Minimum of 10 years of clinical research experience, with minimum of 6 years trial management experience in industry (sponsor or CRO)
  • At least 5 years of vendor management experience is required
  • Masters' degree (MBA, MS or MPH) or PMP certification
  • Experience with monitoring oversight or direct monitoring preferred
  • Strong understanding of clinical trial methodology, drug development process, ICH-GCP guidelines, and applicable regulatory requirements
  • Experience in clinical program management and clinical operations management of clinical trials
  • Highly proficient in MS Office applications
What We Offer:

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.