Clinical Trial Manager II

Description

Overview of Role:

The Clinical Trial Manager 2(CTM2) is an experienced clinical operations professional accountable for all aspects of Clinical Trial Management for global studies. The CTM2 is accountable for study start up and maintenance through study close out, coordinates, leads and drives deliverables for assigned sites, countries, or regions for one or more studies or programs simultaneously. The CTM2s are also accountable for site, country, or region performance metrics and quality of deliverables in the clinical trial.

Role and Responsibilities:

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Partners with the CRO to ensure robust clinical trial execution, data monitoring strategies, and patient enrollment strategies.
• Drafts, reviews and manages study related plans, processes including Informed Consent Forms, Investigator agreements (CTA), CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring as delegated.
• Reviews and approves essential document packages.
• Tracks and ensures resolution of Risk Based Quality Management actions and signals.
• Conducts sponsor oversight of CRO monitoring activities by reviewing all types of monitoring reports; monitors site performance, identifies quality trends, and ensures timely resolution of monitoring findings and action items.
• Performs quality oversight visits.
• Reviews clinical data listings, reports and dashboards ensuring data currency and completeness inclusive of laboratory, imaging and other protocol required assessments.
• Identifies trends and follows up on outstanding data issues with CRO and Study team.
• Responsible for oversight on the maintenance and completeness of the TMF, performing periodic 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.
• Ensures inspection readiness.
• Mentors and provides guidance to CTMs, CRAs, and other Clinical Operations team members.
• 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 area preferred
• 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. Global oncology experience preferred.
• Ability to travel internationally to visit clinical sites and study meetings. Amount will vary upon project needs (up to 20%)
• Demonstrated ability to comprehend complex scientific concepts and proficient in reviewing and assessing clinical data.
• Possesses excellent planning, time management, and project coordination skills.
• Demonstrated 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
• Consistently demonstrates the 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