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Director of Clinical Data Management

HireNexus

This is a Full-time position in Chicago, IL posted February 22, 2021.

Director of Clinical Data Management

This position is with a VC backed technology startup looking to disrupt the clinical trials industry. The group is in need of a Clinical Data Management lead. This company is located in NYC but the position can work remotely and be located anywhere (limited travel expected)

The Director of Clinical Data Management (CDM) is responsible for leading the Clinical Data function, driving the team’s strategy, capabilities, systems, and deliverables. The Director of CDM is responsible for leveraging new technology and efficient processes to deliver clinical trial data to stakeholders rapidly. The Director of CDM plays a key role in partnering with the technology team on the design and implementation of the proprietary, in-house electronic data capture (EDC) system Additionally, as a core member of the company’s operations leadership team, the Director of CDM partners closely with other leaders across the company, contributing to its broader CRO strategy and build-out.

Key responsibilities will include:

  • Using industry knowledge, experience, and first-principles thinking to drive the company’s Data Management strategy.
  • Builds out and manages the Clinical Data Management team at the company, including, but not limited to, Clinical Data Managers, Database Builders, Medical Coders, and Programmers
  • Leading clinical data strategy across the complete portfolio of studies, ensuring the Data Management team consistently delivers against time, quality and cost targets.
  • Partnering with the Product and Engineering teams in the definition of system requirements for internal technology products including eSource, ePRO, and EDC systems.
  • Partnering with the vendor management, product, engineering, and other teams to develop Data Management workflows to integrate data within the internal and external technology products.
  • Works closely with cross-functional teams from Operations, Medical, Engineering, QA, and more to advance broader CRO capabilities.
  • Lending industry expertise across the company, helping us plot our route toward making clinical trials faster, more efficient, and higher quality.
  • Representing Data Management capabilities to study sponsors, including participating in bid defenses.

Skills/Competency

  • Demonstrated ability to lead Data Management strategy and a Data Management business unit.
  • Deep experience in developing and executing all required controlled documents across complex global clinical trials.
  • A track record of building and leading high performing Data Management teams.
  • Thorough knowledge and understanding of 21 CFR, Part 11, International Council of Harmonization E6(R2), Good Clinical Data Management Practice (GCDMP), and applicable federal and international regulations and guidance.
  • Expertise in the clinical technology landscape including software and digital systems used in clinical research.
  • Critical thinking skills with the ability to rethink legacy assumptions in the clinical research space and develop efficiencies wherever possible..
  • Cross-functional partnership skills and the ability to work across an organization’s functional groups to achieve objectives and meet timelines.
  • Solid written and oral communication skills with the ability to synthesize complex concepts and deliver messages clearly.

Job Requirements:

Education and Experience

  • 4+ years of Data Management experience at a sponsor or CRO
  • 4+ years leading Data Management teams
  • BS required, preferably in life sciences or a related field
  • CCDM certified or GCDMP expertise preferred

WHAT CANDIDATES SAY ABOUT THIS RECRUITER:
I was very impressed with Nate’s attention to detail and making sure I had as much information and guidance as possible prior to my phone interview. His comments helped understand the employer’s perspective better.
Bruce, Chief Operating Officer in Kentucky


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