Lead cross-functional teams to ensure studies are conducted on time, with quality and within budget
Develop and maintain study timelines through collaboration with internal and external stakeholders; ensure timelines remain on track through ongoing communication, collaboration and risk-mitigation strategies
Drive study start-up activities, including site and vendor identification, feasibility and selection
Effectively model and manage patient enrollment forecasts; implement risk mitigation strategies to ensure enrollment remains on track
Develop oversight plans for outsourced services; oversee vendors, including CROs, third-party vendors and consultants to ensure the timeliness and quality of services performed
Partner with CMC/clinical supplies to calculate drug projections and contribute to design and packaging of study supplies
Oversees monitoring and monitor performance, including adherence to the monitoring plan and applicable SOPs
Conduct monitoring oversight visits and site engagement visits to ensure the quality of vendor and site performance
Ensure effective and timely contract and budget negotiations with clinical sites and vendors
Lead and/or contribute to study risk assessment and risk mitigation. Proactively communicate risks to study members and senior staff.
Oversee the management of the electronic Trial Master File (TMF); ensure the TMF is created, maintained, monitored and closed out in accordance with the TMF plan and study timelines
Facilitate and manage cross-functional interactions with internal and external stakeholders to ensure relevant and timely communication of information and materials for decision making purposes as well as ensure adherence to study timeline.
Collaborate with medical research, data management, biostatistics, pharmacovigilance, and other functions to ensure data is processed in a timely manner for ongoing data review, interim analyses and final database lock.
Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, DSURs, monitoring plans and reports.
Review and approve corrective action plans, participate in study-related audits.
Actively contribute to and implement best practices and standards for study management; participate in the development of initiatives and process improvement within Clinical Operations
Approach problem solving with a strategic, action oriented and positive attitude.
Manage/mentor/train junior staff by actively participating in documentation, sharing industry standards, implementation of trial conduct best practices, and lessons learned
Assist with the development of policies, procedures and best practices in support of operational excellence
Other duties as assigned.
A Bachelor’s degree or higher degree (scientific discipline preferred)
CPM: 4-7 years in trial management with a sponsor company managing various phases of clinical trials.
Associate Director: at least five (8) years in trial management with a sponsor company managing various phases of clinical trials.
Experience overseeing vendors, including identification and mitigation of risks.
Experience leading cross-functional teams and meetings.
In-depth understanding of ICH/GCP guidelines and FDA regulations.
Understanding/working knowledge of Microsoft Word and Excel and Microsoft Project.
Critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive study(ies) and understand implications of decisions that affect study outcomes and timelines.