SUMMARY/JOB PURPOSE:

SUMMARY/JOB PURPOSE:

The Senior Clinical Trial Technology Manager works independently and cross-functionally with internal stakeholders (Clinical Operations, Data Management, Biometrics, Clinical Supply, QA, Strategic Sourcing and Procurement, Clinical Programming, Clinical Development, and Clinical Science) to support the implementation and maintenance of IxRS systems and other Clinical Technology suppliers to support Exelixis clinical trials. This role provides program-level oversight to Clinical Technology suppliers. This role will conduct training on standards, processes, and metrics for the consistent conduct of Exelixis trials.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

·       Lead development and documentation of study-level business and system requirements with internal stakeholders and technology suppliers.

·       Lead the governance and oversight of IxRS, Imaging, ECG, eCOA, and other Clinical Technology suppliers.

·       Provide study-level technical oversight and support towards designing, implementing, and maintaining the IxRS to support Exelixis trials. 

·       Provide study parameters and requirements for RFPs and Scope of Work for evaluation, selection, and startup of technology suppliers

·       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 clinical technology suppliers to develop user requirements that satisfied business requirements.

·       Manage supplier and internal teams for timelines and associated activities

·       Identify and track study-related technical and escalated issues to resolution.

·       Manage communications and expectations between the study team, internal stakeholders, and clinical technology suppliers.

·       Provide input to IxRS design and specifications and reviewer of IxRS supplier’s documents (e.g., user requirements).

·       Create test plans for user acceptance test (UAT) and conduct UAT for IxRS and eCOA

·       Work to identify metrics and solutions for trend analysis of potential and current issues.

·       Collect, track, and analyze supplier performance metrics. Ensure Clinical Technology suppliers provide service and support as outlined in contract terms and based on agreed-upon performance goals.

·       Provide imaging protocol deviation surveillance oversight as well as SOP change management and deviation surveillance.

·       Perform periodic clinical data systems user audits.

·       Support records retention management.

 

SUPERVISORY RESPONSIBILITIES:

 

No direct reports.

 

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

 

Education/Experience:

·       BS/BA degree in related discipline and a minimum of nine years of related experience; or,

·       MS/MA degree in related discipline and a minimum of seven years of related experience; or,

·       PhD in related discipline and a minimum of two 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 is preferred.

·       Previous experience working in a fast-paced, entrepreneurial environment is preferred.

·       Experience in clinical operations, supplier management, and cross-functional team leadership is preferred.

·       Experience with Microsoft Office applications (Outlook, Word, Excel, Visio, PowerPoint). 

·       Experience in imaging or clinical supply or CRO experience is preferred.

·       Experience in radiographic imaging in a clinical environment preferred.

·       Experience in RECIST 1.1 preferred.

 

Knowledge/Skills:

·       Has extensive experience in relevant industry/profession.

·       Well-versed and Knowledgeable in Good Clinical Practice and FDA regulations.

·       Well-versed and 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 the development of company objectives and principles and to achieve goals in creative and effective ways.

·       Experienced in Interactive Response Technologies, including design, testing, deployment, user management, and report generation.

·       Experienced in Clinical Trial Databases (e.g., EDC, CTMS).

·       Previous experience implementing a clinical system.

·       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.

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.

 #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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $141,500 - $201,000 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.