Associate Clinical Data Management Director (Biotechnology / Oncology)
Exelixis, Alameda, California, United States, 94501
divh2Oncology Data Management Lead/h2pProvide 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./ppEssential Duties And Responsibilities:/pulliAs 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/liliLead the planning and execution of data management activities on assigned studies/liliEnsure all Data Management study documents are developed and archived/liliEstablish and lead the Data Working Group (DWG) for assigned study/liliDevelop and maintain Data Management timelines/liliTrack and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting/liliEffectively identify and mitigate risks to Data Management deliverables/liliIdentify and resolve data handling related issues/liliProvide a high level of expertise in data management to support clinical studies./liliProvide 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./liliDevelop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock./liliManage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding./liliSupport the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects./liliPrepare recommendations for new or improved processes for data management and data flow./liliWork collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met./liliDirect and oversees activities of Data Management staff assigned to studies and tasks within projects/liliPerform project level resource management in conjunction with CDM Management/liliLead electronic submission activities for Data Management as appropriate./liliParticipate in selecting outsourcing partners for assigned studies including:/liliInput to Request for Proposal (RFP)/liliReview proposals/liliParticipate in evaluation/audits and capabilities presentations/liliReview project scope of work documentation/liliProvide oversight of vendors providing Data Management services/liliDevelop and execute study specific training of staff within a project/liliLead or participate in CDM process improvement initiatives/liliPromote and be an advocate for CDM internally and externally./liliDirect the activities and hold accountable junior data managers and/or data review teams/li/ulpSupervisory Responsibilities:/pulliNo direct reports/li/ulpEducation/Experience/Knowledge
Skills:/pulliBS/BA degree in related discipline and a minimum of 11 years of related experience; or,/liliMS/MA degree in related discipline and a minimum of 9 years of related experience; or,/liliPhD in related discipline and a minimum of 5 years of related experience; or,/liliEquivalent combination of education and experience./liliMay require certification in assigned area./li/ulpExperience/The Ideal for Successful Entry Into Job:/pulliTypically requires a minimum of 9 years of related experience and/or combination of experience and education/training./liliA minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials./liliA minimum of 4 years in a project leadership role/liliExperience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred./liliDemonstrated experience leading data management teams is preferred/li/ulpKnowledge/Skills:/pulliThe ability to problem solve and have people/project leadership skills./liliKnowledge of GCP is essential./liliGeneral knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDc) systems required/liliExpertise in CDASH/CDISC standards preferred./liliHas extensive experience in relevant industry/profession and area of specialization./liliUses professional concepts and company objectives to resolve complex issues in creative and effective ways./liliIdentifies and implements methods and procedures to achieve results./liliLeads 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./liliPerforms a variety of complicated tasks with a wide degree of creativity and latitude./liliHas complete understanding and wide application of technical principles, theories, concepts, and techniques./liliHas good general knowledge of other related disciplines./liliApplies strong analytical and business communication skills./liliDemonstrated Data Management Project Management skills/liliExcellent verbal and written communication skills and interpersonal skills are required./li/ulpJob Complexity:/pulliUtilizes appropriate CDM concepts and resources to solve moderately complex technical CDM issues/liliWorks independently and consults with management on decisions affecting project delivery as appropriate/liliDrives 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./liliRegular inter-organizational and outside contacts on routine matters./liliWorks 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./liliExercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results./liliNetworks with key contacts outside own area of expertise/li/ulpWorking Conditions:/pp#LI-JD1/p/div
Skills:/pulliBS/BA degree in related discipline and a minimum of 11 years of related experience; or,/liliMS/MA degree in related discipline and a minimum of 9 years of related experience; or,/liliPhD in related discipline and a minimum of 5 years of related experience; or,/liliEquivalent combination of education and experience./liliMay require certification in assigned area./li/ulpExperience/The Ideal for Successful Entry Into Job:/pulliTypically requires a minimum of 9 years of related experience and/or combination of experience and education/training./liliA minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials./liliA minimum of 4 years in a project leadership role/liliExperience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred./liliDemonstrated experience leading data management teams is preferred/li/ulpKnowledge/Skills:/pulliThe ability to problem solve and have people/project leadership skills./liliKnowledge of GCP is essential./liliGeneral knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDc) systems required/liliExpertise in CDASH/CDISC standards preferred./liliHas extensive experience in relevant industry/profession and area of specialization./liliUses professional concepts and company objectives to resolve complex issues in creative and effective ways./liliIdentifies and implements methods and procedures to achieve results./liliLeads 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./liliPerforms a variety of complicated tasks with a wide degree of creativity and latitude./liliHas complete understanding and wide application of technical principles, theories, concepts, and techniques./liliHas good general knowledge of other related disciplines./liliApplies strong analytical and business communication skills./liliDemonstrated Data Management Project Management skills/liliExcellent verbal and written communication skills and interpersonal skills are required./li/ulpJob Complexity:/pulliUtilizes appropriate CDM concepts and resources to solve moderately complex technical CDM issues/liliWorks independently and consults with management on decisions affecting project delivery as appropriate/liliDrives 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./liliRegular inter-organizational and outside contacts on routine matters./liliWorks 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./liliExercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results./liliNetworks with key contacts outside own area of expertise/li/ulpWorking Conditions:/pp#LI-JD1/p/div