Manager / Sr. Manager, Clinical Data Management

Department: Biometrics

Location: South San Francisco, California, United States

The Clinical Data Management (CDM) department plays an integral role as part of the cross-functional study team. CDM are responsible for the collection, organization, and integrity of data collected as part of our clinical trials and other sample accrual programs.

We are looking for a highly motivated, quality-focused individual who can work collaboratively in a fast-paced, cross-functional team environment. The Manager, CDM, will oversee data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals. This individual will play a key role in ensuring complete, accurate, high quality clinical data for outsourced trials.

Key Responsibilities include:

  • Leading CDM activities across multiple studies
  • Representing CDM in cross-functional meetings
  • Ensuring CDM project deliverables are completed on time and in accordance with quality standards and requirements
  • Applying effective vendor management throughout the study
  • Ensuring complete and accurate CDM documentation
  • Performing thorough development testing of the eCRF and clinical database prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans and executing testing
  • Ensuring accurate development and execution of data integrations between EDC, IXRS and/or external vendor data sources
  • Managing data transfers for assigned studies, including creation of data transfer agreements
  • Participating in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
  • Performing supplemental data reviews according to the data quality checks outlined in the data review plan
  • Participating in reviews of blinded TFL outputs prior to final database locks
  • Reporting query trends and data/query/SDV metrics to the Study Management Team (SMT)
  • Leading the development of EDC custom report specifications or SAS Clinical Programming report specifications as needed
  • Participating in the development and/or enhancement of CDM department standards, operational procedures, and best practices

Preferred Experience Includes:

  • Not sure if you are qualified for this position?  We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants.  You are encouraged to apply even if you do not meet each of the listed preferred qualifications.
  • Bachelor’s degree with 8+ years of relevant industry experience; candidates at the Senior Manager level should have additional years of experience
  • Very detail-oriented, thorough, and organized
  • Able to perform under tight timelines whilst balance conflicting priorities
  • Versatile communicator with strong interpersonal skills
  • Ability to work effectively in both a team setting and independently
  • Comfortable working in a highly regulated environment and understand relevant regulatory requirements
  • Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
  • Proficient in Medidata Rave
  • Exposure to other EDC platforms is a plus
  • Experience of working with and managing CROs
  • Experience with programming techniques, such as SAS, is a plus
  • Willing to travel if required

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