Clinical Trial Technologies Analyst - Exelixis : Job Details

SUMMARY/JOB PURPOSE:

The Clinical Trial Technologies Analyst works with cross-functional teams and internal stakeholders (Clinical Operations, Data Management, Biometrics, Clinical Supply, QA, Strategic Sourcing and Procurement, Clinical Programming, Clinical Development, and Clinical Science) and Clinical Trial Technology Suppliers to support Exelixis clinical trials. The Clinical Trial Technologies Analyst supports, coordinates, and schedules training on standards, processes, and metrics for the consistent conduct of Exelixis trials.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Liaise with internal stakeholders on troubleshooting systems and operational issues (e.g., maintenance, functionality user access) as needed

• Assist in the oversight and management of technology supplier(s).

• Collect, track and analyze technology supplier(s) performance metrics.

• Read and understand project protocol documents. Participating in project meetings, conference calls, and training calls.

• Review status report(s) and query report(s), identify issue trends and provide updates to study teams.

• Monitor cross-study technical and operational issues and manage escalated issues to resolution.

• Assist in imaging protocol deviation surveillance oversight and provide regular updates to internal stakeholders

• Ensure the Data Protection Act is applied to all subject data and that subject confidentiality is maintained at all times.

• Support and coordinate study site start-up activities with Clinical Operations and technology suppliers (e.g. IxRS, Imaging, eCOA, ECG)

• Manage communication between study teams, internal stakeholders, and the supplier(s).

• Execute and document results of test scenarios for user acceptance test (UAT).

• Assist with CRO and Clinical Technology Suppliers in monitoring and resolving data discrepancies.

• Provide support to the Senior Team Members on study-related duties during Pre and Post Post Production site enablement activities

• Assist with identifying metrics and solutions for trend analysis of potential and current issues.

• 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 three years of related experience; or,

• MS/MA degree in related discipline and a minimum of one year of related experience; or,

• An equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Experience in biotech/pharmaceutical industry is preferred.

• Experience in Clinical Operations, Imaging Core Lab, or IxRS supplier experience is a plus.

• Experience in radiographic imaging in a clinical environment is a plus.

• Experience in RECIST 1.1 is a plus.

Knowledge/Skills:

• Experience in relevant industry/profession.

• Sound knowledge of Good Clinical Practice and FDA regulations.

• Familiarity with the clinical trials process and/or experience working in an Imaging Core Lab and ECG (Suppliers) environment is preferred.

• Familiar with Interactive Response Technologies, including design, testing, deployment, user management, and report generation.

• Working knowledge of clinical trial databases (e.g. EDC, CTMS).

• Ability to work in a fast-paced environment.

• Strong organization and communication skills.

• Excellent attention to detail and orientation toward meticulous work.

• Proficient in Excel, Word, PowerPoint, and Visio.

JOB COMPLEXITY:

• Ability to communicate complex technical issues to non-technical stakeholders.

• Ability to prioritize and manage time-sensitive tasks for multiple projects.

• Performs various complicated tasks with a wide degree of creativity and latitude.

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work.

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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 $84,500 - $120,500 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.

DISCLAIMERThe 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.