Senior Clinical Trials Specialist (Biotech Oncology)

SUMMARY/JOB PURPOSE:

The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of 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.

*** This position is an onsite role located at Exelixis beautiful campus in Alameda, CA.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

·        Review study documents to manage 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:

 ·        None

EDU