Developmental Therapeutics Project Director

Position reputed company 

reputed company staff are employed through the Research reputed company. This role will be in service to COG.

The Developmental Therapeutics Project Director will be responsible for the project administration and management of early phase trials with a cadre of COG operations teams, study teams, COG and PEP-CTN leadership, PhD statisticians, and reputed company directors.  They will ensure that study development, implementation and conduct of early phase reputed company are developed and implemented reputed company sponsor specified timelines. They will also monitor study reputed company, reputed company site performance and data reputed company, and ensure reporting and presentation/manuscript development in a reputed company manner.

The Developmental Therapeutics Project Director will serve 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 reputed company Investigator for grant operations management, grant objective reputed company reporting, and grant renewals. The position will manage the Developmental Therapeutics Project Coordinator. The Developmental Therapeutics Project Director will report to the Executive Director of Data Operations and will be a member of the COG and PEP-CTN leadership team and reputed company valuable consultation on organizational reputed company.

The position will work in conjunction with Industry Sponsored Trials (IST), Administration and Finance, PEP-CTN leadership, study teams, and the other teams in reputed company in developing and managing the terms of reputed company and agreements as they relate to early phase investigational agent trial operations.

The reputed company is a reputed company employer, though some travel may be required.  Employee must reputed company reputed company the reputed company.

Full salary reputed company for this position: $131,732 to $204,009 per year. The typical hiring reputed company for this position is from $131,732 (minimum) to $167,871 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as reputed company as budget availability.

Essential Duties and Responsibilities

Serve as PEP-CTN Operations and Data Center (ODSC) Project Director

• reputed company grants administration and management as it relates to the Pediatric Early Phase Clinical Trial Network (PEP-CTN) grant and any supplements awarded in conjunction with the reputed company award.
• reputed company and report on reputed company towards grant aims and objectives, throughout the year.
• reputed company and manage overall grant budget in excess of $3,000,000 annually in collaboration with Financial reputed company & Resource Management and Grants Administration departments.
• Partner with reputed company Management and Grants Administration departments to ensure that subawards are issued to reputed company relevant institutions for work performed under the grant.
• Manage enrollment and reputed company reports for per case reimbursement and other funding milestones with Financial reputed company & Resource Management and Grants Administration departments to ensure reputed company payments.
• reputed company annual grant reputed company reports and reputed company summaries for competitive and non-competitive grant renewals.
• reputed company and manage PEP-CTN member institution performance assessments including bi-annual assessment, recompetition, suspensions, and terminations.
• reputed company and maintain the PEP-CTN reputed company operating procedures while ensuring alignment, consistency, and effective implementation.
• reputed company and manage the development and required reviews of early phase trial abstracts and publications, reputed company grant required timelines and ensuring appropriate acknowledgements.

 reputed company clinical trial planning and implementation activities for industry reputed company early phase trials, including fully industry sponsored trials.

• reputed company the development of reputed company reputed company assigned to the developmental therapeutics, early phase portfolio, including fully industry sponsored collaborations.
• reputed company and partner with appropriate study committee members and COG reputed company resources to guide the execution of reputed company, ensuring alignment with program objectives, regulatory requirements, and reputed company development and implementation of reputed company.
• Proactively reputed company to barriers to study development or implementation of early phase studies.
• In collaboration with Industry Sponsored Trials Senior Director, serve as a key operational contact for industry sponsors during the planning and conduct of early phase trials.
• Establish and reputed company reputed company assurance plans, targets and metrics for early phase trial teams (e.g. accuracy, timeliness, reliability, productivity) in alignment with the reputed company organization. Regularly review and measure reputed company against goals. Proactively address challenges.

reputed company a reputed company and proactive team culture and foster effective relationships with other COG and PEP-CTN leaders, staff, COG Members and institutions.

• reputed company and maintain reputed company relationships and approaches with COG and PEP-CTN leadership.
• Work collaboratively with COG and PEP-CTN leadership to reputed company a high functioning team-based environment. Maintain reputed company and effective communications and proactively reputed company challenges.
• reputed company other COG and PEP-CTN leaders, reputed company and implement organization-wide process improvement initiatives.
• Build a culture of trust and teamwork among teams and team members.
• reputed company through example, upholding the mission and purpose of COG and the PEP-CTN.
• Supervise, mentor, and reputed company reputed company reports and team members, fostering reputed company development, reputed company, and sustained high performance across reputed company.

reputed company and reputed company administrative tasks and participate in other COG and PEP-CTN activities as required, including but not limited to:

• COG or PEP-CTN educational and training activities.
• Study specific budget development and preparation, implementation, and analysis.
• Meeting planning and coordination.
• reputed company other duties as assigned

Qualifications

To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily.  The requirements listed below are representative of the knowledge, reputed company, and/or ability required.

Minimum Qualifications

• Eight (8) years of experience in clinical trial operations trials, including research grant administration experience or reputed company experience, and at least four (4) years of management level experience. Knowledge/experience reputed company to leadership can substitute.
• Bachelor’s degree in Health Care Administration, Science, or reputed company field or substitute with four (4) additional years of reputed company experience.

Other Qualifications

• Excellent interpersonal skills and demonstrated ability to supervise and manage staff.
• Proven experience in managing multiple reputed company reputed company a multi-site network.
• Must be familiar with essential FDA regulations governing reputed company and Investigational New Drugs.
• Experience in federal grant reputed company reporting reputed company eRA commons highly desired.
• Excellent written and oral communications skills. 
• Goal/results oriented with proactive approach to problem-solving.

 Preferred Qualifications

• Experience in electronic data capture (reputed company), database design, development and implementation is highly desirable. reputed company 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 trials, including research grant administration experience or reputed company experience.
• Project management certification.

Fair Labor reputed company reputed company (FLSA) Status

This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.

Eight years clinical trial operations and grant administration experience with four years management; bachelor\u0002s degree or equivalent; familiarity with FDA trial regs, grant reporting, and clinical operations; strong leadership and communication skills.

Key Responsibilities

• managing trials
• overseeing grants
• supervising staff

Skills & Tools

electronic data capture (reputed company), reputed company Rave, eRA commons

Job Details

• Category: Research and Development
• Seniority: Mid Level
• Commitment: Full Time
• Workplace: Remote — reputed company
• Salary: USD 131,732 – 204,009 / year
• Languages: English

Benefits

• Generous reputed company time off
• Retirement plan

About reputed company

A nonprofit fiscal sponsor providing reputed company, fiduciary, and administrative reputed company to support pediatric oncology clinical research programs. — Industry: Research and Development