Associate Director, Data Management

Jounce seeks an experienced and highly motivated individual to join the Statistics and Data Management team in Cambridge, Massachusetts. As a member of the Clinical Development team, the Associate Director, Data Management will manage CROs and the internal data management team within the Statistics and Data Management Department. This position will lead and set the strategic direction for all data management activities in support of RAVE studies across all stages of clinical drug development.

Responsibilities

Lead the data management activities in support of multiple Jounce clinical programs to include:

  • Oversee all data management (DM) activities; lead relevant DM efforts to coordinate interim data cuts to support various activities, with regard to multiple clinical programs; oversee database lock activities and ultimate archiving of study data; direct the overall data management (DM) standards and processes
  • Manage and develop direct reports, help individuals craft their career development plans, and provide on-job training opportunities for DM personnel
  • Lead eCRF development (by external vendor or internal) and facilitate cross-functional reviews of eCRF content; direct database building activities, including review of edit check specifications and performance of user acceptance testing
  • Monitor data collection, coding, and cleaning by CROs through tracking of study metrics and targeted data reviews
  • Review data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation prepared internally or by external vendors
  • Lead the development and implementation of standard DM workflows and infrastructure strategy (such as preferred provider interactions, Jounce TA standard CRFs, SOPs, and templates) that reflects data collection standards, consistent with industry best practice
  • Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
  • Lead the CRF completion training of external vendors and site staff
  • Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
  • As needed, provide data management time and resource estimates to the Head of Statistics and Data Management Department
  • Develop and maintain productive business relationships with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance, and Regulatory Affairs; CROs, central and local laboratories, and other vendors

 

 

Requirements

Education / Experience:

  • S. / B.A. in scientific discipline, M.S. or equivalent preferred, with at least 8 years related experience in a pharmaceutical/biotechnology company and at least 4 years of managerial experience
  • Experience working with various platforms such as Oracle InForm and Medidata Rave
  • Experience with global studies, utilizing an outsourced CRO model
  • Experience with medicational dictionaries, including MedDRA and WHODrug;
  • Experience working with MS Office Suite (Excel, Word and PowerPoint) and familiarity with MS Project.

Skills / Pre-requisites:

  • Expertise in eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
  • Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
  • Good understanding of ICH GCP as well as general knowledge of industry practices and standards
  • Leadership demonstrated in managing DM activities and DM personnel (internal or CROs); ability to be responsive in a fast paced environment
  • Excellent organizational and time management skills particularly during tight timelines; great attention to details; capable of working on multiple projects simultaneously

Highly motivated with ability to work independently and as part of a multi-disciplinary team