Clinical Trials Manager (Biotechnology, Oncology)

About the role

The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL).

Responsibilities

• Manages clinical trials, including those conducted through Contract Research Organizations (CROs)
• May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams
• Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab)
• Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight
• Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
• Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation
• Captures and coordinates the preparation, conduct, and presentations at Investigator Meetings
• Affords support for adherence/compliance to study plans (e.g., Verification of Performance (VOP))
• Ensures oversight of regulatory and essential documents
• Serves as a mentor and provides training to Sr. Clinical Trial Specialists (CTS)

Requirements

Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research.

Qualifications

• BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or, MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or, PhD/PharmD in biological sciences or related field and zero or more years of related experience; or, Equivalent combination of education and experience.
• Experience/The Ideal For Successful Entry Into Job: Experience in either starting a study up, maintenance phase, or study close-out
• Experience with development of prospective site-selection criteria Protocol development experience Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
• Familiar with advanced concepts of clinical research Ability to deal with time demands, incomplete information or unexpected events Experience in interactions with outside vendors, e.g., CROs and contract labs Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
• Demonstrated ability to write and present clearly using on scientific and clinical issues terminology Strong organizational and planning skills Strong interpersonal skills and communication skills (both written and oral)
• Ability to work effectively in a team/matrix environment Demonstrated professional collaboration skills Understands departmental processes and implements solutions to address any task-related challenges Identifies and escalates issues that may have a broader impact

Skills

• Knowledge/Skills Experience in either starting a study up, maintenance phase, or study close-out
• Experience with development of prospective site-selection criteria Protocol development experience Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
• Familiar with advanced concepts of clinical research Ability to deal with time demands, incomplete information or unexpected events Experience in interactions with outside vendors, e.g., CROs and contract labs Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
• Demonstrated ability to write and present clearly, especially on scientific and clinical issues Ability to work effectively in a team/matrix environment Demonstrated professional collaboration skills Understands departmental processes and implements solutions to address any task-related challenges Identifies and escalates issues that may have a broader impact

Benefits

Includes comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.