Sr. Manager, Clinical Data Management

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Company: Katalyst HealthCares and Life Sciences

Location: Brisbane, CA 94005

Description:

Responsibilities:
  • Reporting to the Executive Director, CDM, the Senior Manager, CDM will be a highly motivated, quality-focused individual who can work collaboratively in a fast-paced, cross-functional team environment, and will oversee data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals.
  • 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.
  • Act as the single point of contact for all study related data management deliverables across multiple studies.
  • Represent CDM in cross-functional meetings.
  • Cultivate effective and productive working relationships with peers and vendors.
  • Help develop timelines for data cleaning processes to maintain data integrity.
  • Provide input into the development of vendor/contract research organization (CRO) requests for proposal, scopes of work, and onboarding.
  • Manage CDM vendor/CRO service activities in a fully outsourced model from study build to database lock.
  • Ensure complete and accurate CDM documentation on any given study.
  • Participate in study document reviews, such as clinical study protocols, statistical analysis plans, risk management plans, monitoring plans and analysis output review.
  • Provide oversight for clinical data flow with CRO and ancillary vendors including IRT, eCOA, central lab, imaging, and other systems and services, as needed.
  • Manage the CDM section of the Trial Master File.
  • Support the development of company SOPs and work instructions.
  • Support DM related activities associated with regulatory inspections/audits.
  • Assist with strategic planning activities for the CDM department.
  • Provide and present CDM plans and status reports to a broad audience.
  • Maintain awareness of CDM emerging trends and technology to help develop or enhance CDM department standards, operational procedures, and best practices.
Requirements:
  • Bachelor's degree with at least eight (8) years of relevant industry experience.
  • Very detail-oriented, thorough, and organized.
  • Demonstrated project management experience with ability to perform under tight timelines whilst balancing conflicting priorities.
  • Versatile communicative and strong interpersonal skills.
  • Ability to work effectively in both a team setting and independently.
  • Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices.
  • Understand data privacy requirements governing data collection of clinical trial data and information.
  • Proficient in Medidata Rave and/or other EDC platform study builds.
  • Experience of working with and managing CROs/external vendors.

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