Clinical Trial Manager II

The role

The Clinical Trial Manager 2 is an experienced clinical operations professional accountable for all aspects of Clinical Trial Management for global studies. This person coordinates and drives deliverables for assigned sites, countries, or regions and is accountable for performance metrics and quality of deliverables.

What you will do

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Partner with the CRO to ensure robust clinical trial execution, data monitoring strategies, and patient enrollment strategies.
• Draft, review and manage study related plans, processes including Informed Consent Forms, Investigator agreements, CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plan, da
• Review and approve essential document packages.
• Track and ensure resolution of Risk Based Quality Management actions and signals.
• Conduct sponsor oversight of CRO monitoring activities by reviewing monitoring reports.
• Monitor site performance, identify quality trends, and ensure timely resolution of monitoring findings.
• Perform quality oversight visits.
• Review clinical data listings, reports and dashboards.
• Identify trends and follow up on outstanding data issues with CRO and Study team.

Required qualifications

• 6+ years of clinical trial management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
• 5+ years of direct clinical trial management experience including oversight phase II/III clinical trials
• Ability to travel internationally to visit clinical sites and study meetings (up to 20%)
• Ability to comprehend complex scientific concepts and proficient in reviewing and assessing clinical data
• Excellent planning, time management, and project coordination skills
• Ability to identify and manage operational risks and develop effective mitigation strategies
• Ability to work independently and collaboratively to manage and prioritize work in a fast-paced environment
• Ability to solve problems and use sound judgement in relation to regulatory requirements, interactions with external parties, timelines, and moderately to high clinical programs
• Strong planning, communication, and organizational skills
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process

Nice to have

• Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area
• Global oncology experience

Benefits

• bonus
• stock
• benefits

About the company

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.