Clinical Data Manager II at Exelixis, Inc. in Alameda, California

Job Description:

Position Description:
The Clinical Data Manager II will contribute to the implementation and execution of data collection and data quality review in clinical research studies.

Position Requirements:
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provide expertise in data management to support clinical studies performed or managed by Exelixis.
• Assists in the implementation of routine clinical data management activities including discrepancy management, manual data review, data transfers and reporting.
• Assist with authoring of Data Management study plan documents including Data Management Plans (DMP), Data Transfer Plans (DTP) and Data Review Plans (DRP)
• Provide support to Study Lead Data Manager for tracking study progress and identifying issues and risks
• Assist with data transfers with CROs, SAE/AE reconciliation and thesaurus coding processes.
• Assist with the locking, transfer, and archiving of study databases

SUPERVISORY RESPONSIBILITIES:
• None

EDUCATION/EXPERIENCE/SKILLS:
Education and Experience:
• BS/BA degree in related discipline and 5 years of related experience; or,
• MS/MA/PhD/RN degree in related discipline and 3 years of related experience; or,
• Equivalent combination of education and experience.

Experience:
• Typically requires a minimum of 9 years of related experience or the equivalent combination of experience and education/training.
• A minimum of 3 years of clinical data management experience is also required in the bio/pharmaceutical industry or clinical trials.

Knowledge/Skills/Abilities:
• Knowledge of GCP is essential.
• Familiarity with FDA regulations that govern the execution of clinical trials
• Understanding of drug development and clinical trials
• Ability to perform multiple data management tasks while meeting timeline and quality expectations
• Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications preferred.
• Experience with electronic data capture (EDC) is preferred.
• Experience with oncology clinical trials is preferred.
• Strong analytical and business communication skills are required
• Ability to identify and communicate issues and risks.
• Demonstrated problem solving skills
• Familiarity with FDA regulations that govern the execution of clinical trials
• Understanding of drug development and clinical trials
• Ability to perform multiple data management tasks while meeting timeline and quality expectations
• Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications preferred.
• Experience with electronic data capture (EDC) is preferred.
• Experience with oncology clinical trials is preferred.
• Strong analytical and business communication skills are required
• Ability to identify and communicate issues and risks.
• Demonstrated problem solving skills

JOB COMPLEXITY:
• Frequent use and application of technical standards, principles, theories, concepts and techniques.
• Develop solutions to routine technical problems of limited scope.
• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Works under general supervision.
• Follows established procedures.
• Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.
• Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
• Regular inter-organizational and outside contacts on routine matters.

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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