Senior Technical Operations IxRS Specialist at Exelixis, Inc. in Alameda, California

Job Description:

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Position Description:

The Senior Technical Operations IxRS Specialist works cross-functionally with internal stakeholders (Clinical Operations, Data Management, Biostatistics, Clinical Supply, QA, Outsourcing, and Clinical Science) to support the development, testing, implementation and maintenance of IwRS/IvRS/IxRS to support Exelixis clinical trials. The role assists with conducting training on IxRS standards and processes for the consistent conduct of Exelixis trials.

Position Requirements:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Assist in study-level technical oversight and support towards the design, implementation and maintenance of the IxRS to support Exelixis trials.
• Assist in development and documentation of study-level IxRS business requirements, with internal stakeholders and technology supplier(s).Provide input to IxRS design and specifications.
• Review IxRS supplier's documents (e.g. user requirements specifications).
• Identify and track IxRS-related issues to resolution.
• Liaise directly with internal stakeholders on troubleshooting system issues (e.g. maintenance, functionality user access) as needed
• Manage communication between study teams, internal stakeholders and the IxRS supplier(s).
• Execute and document results of test scenarios for user acceptance test (UAT).
• Work with Management to identify metrics and trend analysis models for potential and current issues.
• Assist in the oversight and management of technology supplier(s).
• Collect, track and analyze technology supplier(s) performance metrics.
• Provide support to the Management on study related duties during Pre and Post Post Production site enablement activities
• Support records retention management.

SUPERVISORY RESPONSIBILITIES:
• None

EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and a minimum of five years of related experience; or,
• MS/MA degree in related discipline and a minimum of three years of related experience; or,
• Equivalent combination of education and experience.

Experience:
• Experience in Biotech/Pharmaceutical industry preferred.
• Previous experience working in a fast-paced, entrepreneurial environment preferred.
• Experience with Microsoft Office applications (Outlook, Word, Excel, Visio, PowerPoint)
• Experience in clinical operations or clinical drug supply and cross-functional teams preferred.

Knowledge/Skills/Abilities:
• Working knowledge interactive response technologies (e.g., IWRS, IVRS, IXRS), including design, testing, deployment, user management and report generation
• Familiar with clinical trial databases (e.g. EDC, CTMS)
• Possess 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 development of company objectives and principles and to achieve goals in creative and effective ways.
• Develop technical and/or business solutions to complex problems.
• Identify and implements 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.

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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.