Senior Clinical Trial Manager.

Overview of Role:

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 coordinates, 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.
• Oversees and provides strategic leadership to site selection, feasibility, enrollment, monitoring issue escalation and close out activities. and operational oversight for global clinical trials from study start-up through closeout.
• Serves as the primary operational lead and escalation point for CROs, ensuring high-quality study execution, data monitoring strategies and enrollment strategies by developing and implementing strong patient enrollment, retention, and data quality strategies.
• Drafts, reviews and approves 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, and safety monitoring activities.
• Reviews and approves essential document packages and critical study deliverables.
• Leads Risk Based Quality Management activities and ensures timely resolution of signals and actions. Ensuring study performance metrics and proactively identifies risks, trends, and mitigation strategies.
• Leads sponsor oversight of CRO monitoring activities by reviewing monitoring trip reports; evaluates monitoring quality, identifies cross site trends and risks, and drives timely resolution of critical findings and action items.
• Performs quality oversight visits with a focus on inspection readiness.
• Leads and reviews clinical data listings, reports and dashboards ensuring data currency and completeness inclusive of laboratory, imaging and other protocol required assessments. Identifies data trends and risks, drives cross functional resolution of critical issues to maintain inspection readiness.
• Oversees maintenance, quality, and completeness of the Trial Master File (TMF) and leads TMF quality reviews.
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements.
• Leads preparation for audits and regulatory inspections and supports inspection management activities.
• Manages, mentors and provides guidance to CTMs, CRAs, and other Clinical Operations team members.
• Drives continuous improvement initiatives and contributes to development of Clinical Operations processes and standards.
• Represents Clinical Operations on cross-functional study teams and governance meetings.
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• 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. Amount will vary upon project needs (up to 20%)
• Proven capabilities to interpret complex scientific concepts with proficiency in reviewing analyzing and critically assessing clinical data to support trial execution and decision making.
• Proven proficiency in overseeing large complex studies being managed in house and by a CRO
• Demonstrated ability to problem-solve in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Demonstrated ability to lead teams and work in a fast-paced team environment
• Demonstrated ability to solve problems and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
  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 and the ability to apply this knowledge to complex, global studies.