Associate Director, Data Management

Location
Lexington, MA
Posted
Aug 20, 2019
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time

Position Summary 

Associate Director, Data Management at Wave Life Sciences will be responsible for the data management activities for the assigned program and will be a member of clinical study management team.  The successful candidate will proactively oversee execution of CRO outsourced trials from study startup through study closure in support of trial objectives and corporate goals. This position reports to the Head of Data Management.

Key Responsibilities

  • Provide oversight of clinical data management activities across multiple studies within the assigned program.  
  • Oversight of Data Management external vendors (CROs) for outsourced study activities such as CRF development, database set-up activities, data validation process, medical coding, SAE reconciliation, training of study site personnel in CRF completion, lab data transfer specifications, and data clarification processes.  
  • Oversee and perform thorough testing of the eCRFs prior to database deployment and ensure proper documentation of testing per the SOPs.
  • Oversight of data review activities (including internal cross functional listing review, external data reconciliation) ensuring completion of all activities for deliverables, and manage all activities leading to the study database lock.  
  • Where applicable, ensure consistency and data standards are followed across studies in data collection and processes.
  • Provide creative and effective ways to resolve complex data related or system related issues using professional concepts and considering company objectives.
  • Ensure Data Management activities are conducted according to applicable regulations and per the protocol. 
  • Oversee or execute Case Report Form and Completion Guideline development.
  • Oversee or develop Data Management Plan.  
  • Oversee the development of Data Transfer Agreements between the Data Management CRO and the External data vendors. 
  • Serve as lead Data Manager on assigned clinical trials and attend clinical trial study team meetings. 
  • Serve as the technical consultant ensuring appropriate development, maintenance, and use of data capture technologies for assigned projects. 
  • Contribute as a reviewer from Data Management group for study protocols and amendments to the protocols. 
  • Responsible for archival of data and study specific data management documentation. 
  • Independently monitor own activities and project status for successful project deliverables according to timelines.
  • Participate in the review and/or development of SOPs and guidance documents.

Qualifications

  • At least 12 years of clinical data management experience in pharma/biotech/CRO industry. 
  • At least 7 years of Electronic Data Capture (EDC) experience with systems such as Medidata Rave.  
  • Knowledge of CDISC (CDASH, SDTM) and medical coding dictionaries MedDRA, WHO Drug, and Clinical Data Management best practices.  
  • Good understanding of ICH, GCP and other applicable regulatory guidelines.
  • Effective verbal and written communication skills.  
  • Demonstrated ability to work independently on multiple studies with multiple priorities in a fast-paced, team-based environment. 
  • Global clinical trial and CRO management experience. 
  • Requires a bachelor’s degree in a scientific discipline or equivalent.  Master’s degree is preferred.