Clinical Trials Manager (Oncology)

Exelixis•Alameda, CA

2d•$136,000 - $192,500•Onsite

About The Position

The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of solid tumor oncology 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). This position is located at Exelixis beautiful headquarters overlooking the bay in Alameda, CA. Full relocation provided.

Requirements

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 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
Ability to understand technical, scientific, and medical information
Demonstrated success in problem-solving
Ability to anticipate and resolve problems
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
Ability to study, analyze and understand new situations and business problems and identify appropriate solutions
Operationally excellent and drives others towards excellence
Resilient in the context of a rapidly changing environment
Works independently to meet objectives and completes tasks within established timelines.
Organized with a systematic approach to prioritization

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
Coordinates the preparation, conduct, and presentations at Investigator Meetings
Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection
Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials
Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.)
Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines
Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed
Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP)
Ensures oversight of regulatory and essential documents
Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
Coordinates the design, format, and content of study guides and subject instructions
May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC)
May support / be responsible for site and vendor invoice reviews
Reviews and provides oversight of study trackers and metrics
Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc)
May be responsible for department strategic initiatives or process improvements
May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS)