Senior Clinical Trials Specialist (Jr CTM) (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 None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: 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. Experience/The Ideal for Successful Entry into Job: Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: 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 JOB COMPLEXITY Works on assigned problems of moderate scope with analysis of situation or data required. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal and external working relationships. Uses professional concepts and company policies and procedures to solve a variety of routine problems. Demonstrated professional collaboration skills Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS Resilient in the context of a rapidly changing environment Organized with a systematic approach to prioritization Works independently to meet objectives and completes tasks within established timelines. Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS We drive for results, so patients can survive and thrive. We are resilient in the face of adversity, and tireless in advancing our science. We celebrate our long history of prolific drug discovery and rigorous drug development. We unite to launch innovative medicines for difficult-to-treat cancers. We exist to give people hope - one drug, one patient at a time. We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS Travel may be required up to 20% in support of clinical study activities LI-JD1 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 $114,500 - $163,500 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.