Associate Clinical Data Management Director

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.*** This position is located at Exelixis beautiful headquarters overlooking the bay in Alameda, CA. Full relocation providedESSENTIAL 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 timelinesLead the planning and execution of data management activities on assigned studiesEnsure all Data Management study documents are developed and archivedEstablish and lead the Data Working Group (DWG) for assigned studyDevelop and maintain Data Management timelinesTrack and manage progress towards data deliverables through effective metrics tracking, analysis, and reportingEffectively identify and mitigate risks to Data Management deliverablesIdentify and resolve data handling related issuesProvide 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 projectsPerform project level resource management in conjunction with CDM ManagementLead electronic submission activities for Data Management as appropriate.Participate in selecting outsourcing partners for assigned studies including:Input to Request for Proposal (RFP)Review proposalsParticipate in evaluation/audits and capabilities presentationsReview project scope of work documentationProvide oversight of vendors providing Data Management servicesDevelop and execute study specific training of staff within a projectLead or participate in CDM process improvement initiativesPromote and be an advocate for CDM internally and externally.Direct the activities and hold accountable junior data managers and/or data review teamsSUPERVISORY RESPONSIBILITIES:No direct reportsEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience:BS/BA degree in related discipline and a minimum of 11 years of related experience; or,MS/MA degree in related discipline and a minimum of 9 years of related experience; or,PhD in related discipline and a minimum of 5 years of related experience; or,Equivalent combination of education and experience.May require certification in assigned area.Experience/The Ideal for Successful Entry into Job:Typically requires a minimum of 9 years of related experience and/or combination of experience and education/training.A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.A minimum of 4 years in a project leadership roleExperience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred.Demonstrated experience leading data management teams is preferredKnowledge/Skills:The ability to problem solve and have people/project leadership skills.Knowledge of GCP is essential.General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDc) systems requiredExpertise in CDASH/CDISC standards preferred.Has extensive experience in relevant industry/profession and area of specialization.Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.Identifies and implements methods and procedures to achieve results.Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.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.Demonstrated Data Management Project Management skillsExcellent verbal and written communication skills and interpersonal skills are required.JOB COMPLEXITY:Utilizes appropriate CDM concepts and resources to solve moderately complex technical CDM issuesWorks independently and consults with management on decisions affecting project delivery as appropriateDrives the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations will cause delays in program schedules and may result in the allocation of additional resources.Regular inter-organizational and outside contacts on routine matters.Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.Networks with key contacts outside own area of expertiseWORKING CONDITIONS:#LI-JD1If 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 $163,000 - $231,000 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.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.SummaryLocation: Alameda, CAType: Full time