Senior Clinical Trials Specialist (Biotechnology Oncology)

Exelixis Inc.•Alameda, CA

71d

About The Position

The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation.

Requirements

BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or,
MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or,
Equivalent combination of education and experience.
Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research
Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures
Experience with development of prospective site-selection criteria
Familiar with medical terminology, and basic 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
Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
Applies technical standards, principles, theories, concepts and techniques
Advanced computer skills
Good 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
Self-motivation, eagerness to grow professionally and commitment to self-development

Responsibilities

Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively
Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL
Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues
Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals)
Review compound-specific ICF and develop study-specific ICF templates
Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection
Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents
Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites
May coordinate the preparation, conduct, and presentations at Investigator Meetings
Review monitoring visit reports for completeness, accuracy, and adherence to the protocol
Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation
May conduct UAT for EDC / IRT and data listing review of EDC data for analysis
Compile and review appendices for preparation of clinical study reports
Review and/or create study documents (e.g. newsletters, and various study / site trackers)
Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion
Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately
May assist in materials preparation for strategic governance discussions as required

Benefits

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.

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