Developmental Therapeutics Project Director
Location
United States
Posted
19 hours ago
Salary
$131.7K - $204.0K / year
Seniority
Lead
No structured requirement data.
Job Description
Developmental Therapeutics Project Director
COG Research Foundation, LLC
Role Description All staff are employed through the Research Foundation. This role will be in service to COG. The Developmental Therapeutics Project Director will be responsible for: - Project administration and management of early phase trials with COG operations teams, study teams, COG and PEP-CTN leadership, PhD statisticians, and league directors. - Ensuring study development, implementation, and conduct of early phase clinical trials are developed and implemented within sponsor specified timelines. - Monitoring study progress, overseeing site performance and data quality, and ensuring timely reporting and presentation/manuscript development. - Serving as the Pediatric Early Phase Clinical Trial Network (PEP-CTN) Operations Statistics and Data Center (ODSC) Director. - Maintaining a reporting relationship with the PEP-CTN grant Principal Investigator for grant operations management, objective oversight reporting, and grant renewals. - Managing the Developmental Therapeutics Project Coordinator. - Reporting to the Executive Director of Data Operations and being a member of the COG and PEP-CTN leadership team. - Working with Industry Sponsored Trials (IST), Administration and Finance, and other teams in COG Research Foundation, LLC in developing and managing contracts and agreements related to early phase investigational agent trial operations. The COG Research Foundation, LLC is a 100% remote employer, though some travel may be required. Employee must reside within the United States. Full salary range for this position: $131,732 to $204,009 per year. The typical hiring range is from $131,732 (minimum) to $167,871 (midpoint), based on 100% FTE. Qualifications - Eight (8) years of experience in clinical trial operations, including research grant administration experience or related experience, and at least four (4) years of management level experience. - Bachelor’s degree in Health Care Administration, Science, or related field or substitute with four (4) additional years of related experience. - Excellent interpersonal skills and demonstrated ability to supervise and manage staff. - Proven experience in managing multiple projects within a multi-site network. - Familiarity with essential FDA regulations governing clinical trials and Investigational New Drugs. - Experience in federal grant progress reporting via eRA commons highly desired. - Excellent written and oral communications skills. - Goal/results oriented with proactive approach to problem-solving. Requirements - Experience in electronic data capture (EDC), database design, development and implementation is highly desirable. Medidata Rave experience preferred. - Experience in clinical data operations in a comprehensive cancer center, a cooperative group or the pharmaceutical/biotechnology industry is highly desirable. - Ten (10) years of experience in clinical trial operations, including research grant administration experience or related experience. - Project management certification. Benefits - Comprehensive benefit options include medical, dental, vision, 401(k), accrued Paid Time Off (PTO). - Employee Assistance Program (EAP), Flexible Spending Account (FSA), cell phone and internet stipends, wellness stipend, paid holidays, and more. - Employees who work 20 hours or more per week are eligible for these benefit options.
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