Clinical Trial Manager II

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the selection of sites, feasibility studies, activation, enrollment, monitoring, issue escalation, and closeout activities.

• Collaborate with the CRO to guarantee effective clinical trial execution, data monitoring strategies, and patient enrollment methods.

• Develop, evaluate, and oversee study-related plans and processes, which include informed consent forms, investigator agreements, CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management, and safety monitoring as assigned.

• Review and authorize essential document packages.

• Monitor and ensure the resolution of Risk Based Quality Management actions and signals.

• Conduct sponsor oversight of CRO monitoring activities by examining monitoring reports, assessing site performance, identifying quality trends, and addressing findings and action items.

• Execute quality oversight visits.

• Analyze clinical data listings, reports, and dashboards for accuracy and completeness, including laboratory, imaging, and other assessments required by the protocol.

• Recognize trends and follow up on unresolved data issues with the CRO and study team.

• Manage the maintenance and completeness of the TMF and conduct periodic quality reviews.

• Oversee the creation and execution of clinical trial activities in line with Good Clinical Practices and ensure adherence to regulatory requirements.

• Guarantee inspection readiness.

• Mentor and provide guidance to CTMs, CRAs, and other members of the Clinical Operations team.

• Carry out other assigned responsibilities.

⛳️ Requirements

• Bachelor's degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or another health/medical-related field is preferred.

• 6+ years of experience in clinical trial management, specifically in conducting international clinical trials within sponsor Pharma/Biotech organizations.

• 5+ years of direct clinical trial management experience, including oversight of phase II/III clinical trials.

• Willingness to travel internationally to visit clinical sites and attend study meetings, up to 20% of the time.

• Ability to understand complex scientific concepts and demonstrate proficiency in reviewing and evaluating clinical data.

• Strong planning, time management, and project coordination abilities.

• Capability to identify and manage operational risks, along with developing effective mitigation strategies.

• Ability to work both independently and collaboratively in a fast-paced environment.

• Strong problem-solving skills and sound judgment concerning regulatory requirements, interactions with external parties, timelines, and moderately to highly complex clinical programs.

• Excellent planning, communication, and organizational skills.

• Comprehensive knowledge of the drug development process, ICH guidelines/GCP, and each phase within the clinical trial process.

🏝️ Benefits

• Potential bonus.

• Stock options.

• Comprehensive benefits package.

• Additional applicable variable compensation.

• Commitment to Equal Opportunity Employment and a diverse work environment.