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SUMMARY/JOB PURPOSE: The Clinical Trial Technologies Manager works independently with internal stakeholders (Clinical Operations, Data Management, Biometrics, Clinical Supply, QA, Strategic Sourcing and Procurement, Clinical Programming, Clinical Development, and Clinical Science) and with Clinical Technology suppliers to support Exelixis clinical trials. This role provides study-level technical oversight to technology suppliers, as well as implementation and maintenance of the IxRS. It will assist with conducting training on standards and processes for the consistent conduct of Exelixis trials. ESSENTIAL DUTIES AND RESPONSIBILITIES:
Provide study-level technical oversight and support towards designing, implementing, and maintaining clinical systems (e.g., IxRS, Imaging, eCOA, ECG) and technology to support Exelixis trials. Lead development and documentation of study-level business and system requirements with internal stakeholders and technology suppliers. Provide study parameters and requirements for RFPs and Scope of Work for evaluation, selection, and startup of technology suppliers Provide study technical parameters and requirements for RFPs and Scope of Work for suppliers evaluation, selection and startup. Provide input on clinical systems design specifications, create test cases, and conduct user acceptance test (UAT) Represent Clinical Trial Technologies group in study team meetings, data working groups, and project workstreams. Act as Lead Clinical Trial Technologies stakeholder when implementing, maintaining, and closing out various clinical systems. Manage technology suppliers to develop user requirements that satisfy business requirements. Review of technical supplier's documents (e.g. user requirements). Manage suppliers and internal teams for project timelines and associated activities Identify and track study-related technical and system issues to resolution. Manage communications and expectations between the study team, internal stakeholders, and the technology supplier. Identify metrics and solutions for trend analysis of potential and current issues. Collect, track, and analyze supplier performance metrics. Ensure that the supplier provides service and support as outlined in the contract terms and based on agreed-upon performance goals. Perform periodic clinical data systems user audits and support records retention management. Establish quality standards, investigate compliance in a timely and efficient manner, and implement service improvement plans when required. Provide imaging protocol deviation surveillance oversight as well as SOP change management and deviation surveillance. Monitor cross-study technical and operational supplier performance and manage escalated issues to resolution. Ensure that the Data Protection Act is applied to all subject data and that subject confidentiality is maintained at all times.
SUPERVISORY RESPONSIBILITIES:
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience:
BS/BA degree in related discipline and a minimum of seven years of related experience; or, MS/MA degree in related discipline and a minimum of five years of related experience; or, PhD in related discipline and zero or more years of related experience; or, Equivalent combination of education and experience. May require certification in assigned area.
Experience/The Ideal for Successful Entry into Job:
Experience in Biotech/Pharmaceutical industry preferred. Previous experience working in a fast-paced, entrepreneurial environment preferred. Experience in imaging or clinical supply or CRO suppliers is preferred. Experience in radiographic imaging in a clinical environment preferred. Experience in RECIST 1.1 preferred.
Knowledge/Skills:
Possess extensive experience in relevant industry/profession. Knowledgeable in Good Clinical Practice and FDA regulations. Knowledgeable of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred. Use broad expertise or unique knowledge and skills to contribute to developing company objectives and principles and achieve goals creatively and effectively. Knowledgeable in Interactive Response Technologies, including design, testing, deployment, user management, and report generation. Knowledgeable in Clinical Trial Databases (e.g., EDC, CTMS). Previous experience implementing a clinical system (e.g., eCOA, IxRS, ECG, CTMS). Develop technical and/or business solutions to complex problems. Identify and implement methods, techniques, procedures, and evaluation criteria to achieve results. Perform a variety of complicated tasks with a wide degree of creativity and latitude. Possess a complete understanding and wide application of technical principles, theories, concepts, and techniques. Possess a good general knowledge of other related disciplines. Apply strong analytical and business communication skills. Proficient in Visio, PowerPoint, Excel, Project, and Word. Ability to communicate complex technical issues to non-technical stakeholders.
JOB COMPLEXITY:
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results. Creates formal networks involving coordination among groups.
WORKING CONDITIONS:
#LI-MB1 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 $116,000 - $165,500 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.
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Exelixis
paid holidays, sick time, 401(k)
Feb 26, 2025