Senior Clinical Trials Specialist (Biotechnology Oncology)

SUMMARY / JOB PURPOSE :

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.

ESSENTIAL DUTIES AND 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

SUPERVISORY RESPONSIBILITIES :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

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EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS :

LIVES THE EXELIXIS CORE VALUES DAILY :

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers 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.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.