Senior Manager Clinical Data Management

Clinical Development Operations Bothell, Washington US Field Based Seattle, Washington


Description

Summary: 

The Senior Manager, Clinical Data Management oversees Data Management activities for Phase I-IV studies and ensures that product and study level deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. The Senior Manager, Clinical Data Management has expert knowledge of FDA regulations and general industry standards and drives departmental infrastructure development. This position will also be responsible for managing salaried and contract CDAs. 

 Principal Responsibilities:

  • Manage CDAs efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews. Perform hiring and training activities as needed.
  • Lead studies and guide team through DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
  • Develop and guide team members through the development of DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
  • Independently perform and guide study team members (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.) through the data cleaning and database lock process in an efficient and timely manner
  • DM Project Management: Understand critical tasks and milestones; ensure data management deliverables are met per study timelines
  • Research, evaluate, and direct departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes are required
  • Align with and support management and corporate objectives
  • Support implementation of data standards
  • Drive and guide complex process and initiatives
  • Communicate and message information to multiple levels of leadership appropriately, applying appropriate level of detail to audience to ensure efficient utilization of resource
  • Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
  • Encourage collaboration through relationship building with other leaders; demonstrate ability to influence without authority
  • May program SAS Non-System Edit Checks (NSECs) and/or SAS Data Listings.  Run SAS programs, review SAS logs, and generate output.  Mentor less proficient SAS users as appropriate
  • Perform study resourcing and budget support as appropriate

 Qualifications:

 Minimum of 10 years of relevant experience 

  • Prior supervisory experience
  • Effective organizational and communication skills
  • Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
  • Detail oriented; performs quality and accurate work
  • Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
  • Previous relevant EDC experience
  • Strong experience and knowledge in the application of data standards
  • Excellent supervisory, problem solving, negotiation and organizational skills
  • Knowledge and understanding of non–CRF data flow, transfer, and integration
  • Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
  • Exhibits composure and strong conflict management skills
  • Prior experience managing vendors/CROs

Preferred: 

  • Previous experience with RTSM/IWRS and ePRO systems
  • SAS programming experience
  • Previous experience working on oncology trials
  • Previous experience managing, tracking, and reconciling BICR/IRF data 

 Education:

  • BA/BS in relevant field

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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