Technical Operations IxRS Manager

Job Description

The Technical Operations IxRS Manager - works cross-functionally with internal stakeholders (Clinical Operations, Data Management, BioStatistics, Clinical Supply, QA, Outsourcing, and Clinical Science) to support the implementation and maintenance of IxRS systems to support Exelixis clinical trials. Assists with conducting training on standards, processes and metrics for the consistent conduct of Exelixis trials.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Provide study-level technical oversight and support towards the design, implementation and maintenance of the IxRS to support Exelixis trials. Provide study IxRS parameters and requirements for RFPs and Scope of Work for IxRS vendor evaluation, selection and startup Lead development and documentation of study-level business and system requirements, with internal stakeholders and technology suppliers Provide input to IxRS design and specifications Manage IxRS supplier to develop user requirements that satisfy business requirements Primary reviewer of IxRS supplier’s documents (e.g., user requirements) Manage vendors and internal teams for IxRS-related timelines and associated activities Identify and track study-related technical and system issues to resolution Manage communication and expectations between the study team, internal stakeholders and the IxRS supplier Create test scenarios for user acceptance test (UAT) and conduct UAT Work to identify metrics and solutions for trend analysis of potential and current issues Collect, track and analyze supplier performance metrics. Ensure IxRS supplier provides service and support as outlined in contract terms and based on agreed upon performance goals Perform periodic clinical data systems user audits Support records retention management

SUPERVISORY RESPONSIBILITIES: No direct reports

EDUCATION/EXPERIENCE/SKILLS: Education: BS/BA degree in related discipline and seven years of related experience; or, MS/MA degree in related discipline and five years of related experience; or, PhD in related discipline and zero to two years of related experience, or; Equivalent combination of education and experience. May require certification in assigned area.

Experience: Experience in Biotech/Pharmaceutical industry preferred. Experience in clinical operations, supplier management, employee supervision and cross-functional team leadership required.

Knowledge/Skills/Abilities: Has extensive experience in relevant industry/profession. Knowledgeable in Good Clinical Practice and FDA regulations Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred Uses 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. Experience implementing Clinical System Develops technical and/or business solutions to complex problems. Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results. Performs a variety of complicated tasks with a wide degree of creativity and latitude. Has complete understanding and wide application of technical principles, theories, concepts and techniques. Has good general knowledge of other related disciplines. Applies 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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Additional Information

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.