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Clinical Trial Team Manager

System One
New Haven, CT
  • Posted: over a month ago
  • Full-Time
Job Description
Title: Clinical Trial Team Manager
Location: New Haven, CT
Duration: Direct Hire
Schedule: 37.5 hours (occasional OT and weekends)
Target Start Date: ASAP

Responsibilities:
  • Manages and monitors policies, practices and procedures of licensed and unlicensed staff in their assigned translational working group (includes C&T and M&P staff).
  • Hires, trains, supervises and evaluates staff providing direction, training, support on a variety of research topics, including but not limited to: Informed Consent, enrolling study subjects, data management and monitoring/auditing of studies.
  • Collaborate with Therapeutic Working Group Leader (TWG) and Principal Investigator (PI) on assessment and implementation of highly complex trials for the research team. Includes identifying accrual targets, study activation timelines and metrics and resolving potential discrepancies and/or barriers to enrollment by prior to study activation.
  • Manage oversight of protocol conduct and ensure that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements.
  • Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring visits, Multi-disciplinary Team meetings, staff meetings.
Requirements:
  • Bachelor’s degree in a relevant academic/scientific field with Minimum of 4 years of experience in clinical trials research or the equivalent combination of education or experience
  • Proven experience supervising staff.
  • Proven ability to manage and monitor the policies, practices and procedures of licensed and unlicensed staff. Proven ability to develop specific short- and long-term objectives for staff.
  • Demonstrated ability to ensure appropriate infrastructure by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies, and regulation while ensuring participant safety.
  • Strong knowledge of Good Clinical Practice guidelines.
  • Proven ability to interpret federal, state, university and sponsor policies and regulations. Proven ability to interpret complex oncology clinical trial protocols and federal, state, local guidelines.
  • Proven ability to manage several projects concurrently, while balancing competing priorities and deadlines. Extreme flexibility in work focus. Ability to switch among several different projects without any adverse effects.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.


System One

Address

New Haven, CT
USA

Industry

Healthcare

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