Exelixis · 19 hours ago
Senior Clinical Trials Specialist (Biotechnology Oncology)
Alameda, CA
Full-time
Hybrid
Mid, Senior Level
$108K/yr - $153K/yr
5+ years expExelixis is a biotechnology company focused on oncology, and they are seeking a Senior Clinical Trials Specialist to coordinate activities associated with oncology clinical trials. The role involves providing operational support to the Study Delivery Lead by managing study activities, clinical sites, and ensuring accurate study documentation.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Jodie Donaldson
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
Qualification
Required
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
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
2026-01-12
The Motley Fool
2026-01-09
Company data provided by crunchbase