Associate Clinical Data Management Director; Biotechnology​/Oncology

Position: Associate Clinical Data Management Director (Biotechnology / Oncology)
* 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 $160,000 - $226,500 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  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.
***** SUMMARY/

JOB PURPOSE:

** Provide oversight for the execution of oncology data management activities at the program level (for an indication or for multiple studies within an indication) from study start up through to regulatory submission. In collaboration with cross-functional teams, external partners, and support Data Managers, may serve as the lead study data manager for a large, complex trial or multiple, smaller studies.

Will support CDM process improvement initiatives. Participate in staff recruitment, onboarding, training, and mentoring.
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* ESSENTIAL DUTIES AND RESPONSIBILITIES:

*** As the main point of contact to Study Team, work collaboratively with cross-functional team members to meet project deliverables with quality and per agreed timelines
* Lead the planning and execution of data management activities on assigned studies
* Ensure all Data Management study documents are developed and archived
* Establish and lead the Data Working Group (DWG) for assigned study
* Develop and maintain Data Management timelines
* Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
* Effectively identify and mitigate risks to Data Management deliverables
* Identify and resolve data handling related issues
* Provide a high level of expertise in data management to support clinical studies.
* Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
* Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock.
* Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding.
* Support the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects.
* Prepare recommendations for new or improved processes for data management and data flow.
* Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met.
* Direct and oversees activities of Data Management staff assigned to studies and tasks within projects
* Perform project level resource management in conjunction with CDM Management
* Lead electronic submission activities for Data Management as appropriate.
* Participate in selecting outsourcing partners for assigned studies including:
* Input to Request for Proposal (RFP)
* Review proposals
* Participate in evaluation/audits and capabilities presentations
* Review project scope of work documentation
* Provide oversight of vendors providing Data Management services
* Develop and execute study specific training of staff within a project
* Lead or participate in CDM process improvement initiatives
* Promote and be an advocate for CDM internally and externally.
* Direct the activities and hold accountable junior data managers and/or data review teams
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* SUPERVISORY RESPONSIBILITIES:

*** No direct reports
**…