[Hiring] Senior Clinical Trial Manager @Summit Therapeutics

Role Description

The Senior Clinical Trial Manager (Sr. CTM) is a highly experienced clinical operations professional responsible for providing strategic leadership and operational oversight of complex global clinical trials, while leading and driving deliverables at assigned sites, countries or regions. The Sr. CTM is accountable for all aspects of study execution from protocol development support through study closeout and inspection readiness. The Sr. CTM may manage multiple studies or programs simultaneously and provides mentorship and guidance to Clinical Trial Managers and other Clinical Operations personnel.

Role and Responsibilities

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Oversee and provide strategic leadership to site selection, feasibility, enrollment, monitoring issue escalation and closeout activities.
• Serve as the primary operational lead and escalation point for CROs, ensuring high-quality study execution, data monitoring strategies and enrollment strategies.
• Draft, review and approve study-related plans, processes, and documents including:
  • Informed Consent Forms
  • Investigator Agreements (CTA)
  • CRFs
  • CRF Guidelines
  • Statistical/pharmacokinetic analysis plans
  • Monitoring plans
  • Data management plans
  • Safety monitoring activities
• Review and approve essential document packages and critical study deliverables.
• Lead Risk Based Quality Management activities and ensure timely resolution of signals and actions.
• Lead sponsor oversight of CRO monitoring activities by reviewing monitoring trip reports.
• Perform quality oversight visits with a focus on inspection readiness.
• Lead and review clinical data listings, reports and dashboards ensuring data currency and completeness.
• Oversee maintenance, quality, and completeness of the Trial Master File (TMF) and lead TMF quality reviews.
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices.
• Lead preparation for audits and regulatory inspections and support inspection management activities.
• Manage, mentor and provide guidance to CTMs, CRAs, and other Clinical Operations team members.
• Drive continuous improvement initiatives and contribute to development of Clinical Operations processes and standards.
• Represent Clinical Operations on cross-functional study teams and governance meetings.
• All other duties as assigned.

Qualifications

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas preferred.
• 8–10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations.
• 7+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials.
• Ability to travel internationally to visit clinical sites and study meetings (up to 20%).
• Proven capabilities to interpret complex scientific concepts with proficiency in reviewing, analyzing, and critically assessing clinical data.
• Proven proficiency in overseeing large complex studies managed in-house and by a CRO.
• Demonstrated ability to problem-solve in relation to regulatory requirements and complex clinical programs.
• Demonstrated ability to lead teams and work in a fast-paced team environment.
• Excellent planning, leadership, communication, negotiation, and organizational skills.
• Expert knowledge of the drug development process, ICH guidelines/GCP with a deep understanding of all phases of clinical trial execution.

Requirements

• This is the pay for this position: $158,000 - $185,000 USD.
• Actual compensation packages are based on several factors unique to each candidate.
• The total compensation package may also include bonus, stock, benefits and/or other applicable variable compensation.

Company Description

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.