Clinical Data Management Director

4 days ago

Cambridge, Massachusetts, United States Third Harmonic Bio Full time
{"title": "Clinical Data Management Director", "description": "About Third Harmonic Bio

Third Harmonic Bio is a biopharmaceutical company dedicated to developing innovative treatments for severe allergy and inflammation. Our mission is to create a breakthrough treatment for people living with debilitating conditions that impact overall health and well-being.

Our Values

Our values provide the foundation for our culture and operating principles. We hold ourselves accountable and interact with others, partners, and the global medical and patient community with empathy and candor.

The Role

We are seeking a Director of Clinical Data Management to oversee all aspects of the clinical trial data management process from study start-up to database lock. This individual will drive end-to-end study data quality and integrity by providing oversight of contracted Clinical Research Organizations (CROs) and collaborating with the study team.

Responsibilities
  • Lead Data Management contact and contributor for Third Harmonic Bio clinical studies
  • Serve as an active member of Study Teams
  • Provide strong, collaborative oversight of CROs and external vendors in support of timelines and data quality
  • Engage internal and external parties to ensure regular, cross-functional review of data leading to high-quality data delivered on time
  • Oversee the creation of data management documentation (Data Management Plan, CRF Completion Guidelines, etc)
  • Oversee development of EDC databases, edit checks, external data transfers, and reports in support of the protocol and analyses
  • Perform system testing according to UAT (User Acceptance Testing) Plan
  • Regularly review clinical trial data as part of oversight of external vendors
  • Design data listings and visualizations in support of clinical and medical review of data
  • Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
  • Develop Data Management processes and participate in development of clinical data standards at Third Harmonic Bio based on industry standards such as CDASH and SDTM
  • Provide innovative metrics on data management to guide and support clinical operations
Requirements
  • Bachelor's degree in a related field; with at least 7-10 years in the biotechnology or pharmaceutical industry
  • Proficiency in the areas of clinical data collection, cleaning, and analysis
  • Experience overseeing CROs and vendors in clinical trials
  • Experience working in cross-functional team-oriented environments
  • Demonstrates strong project and timeline management skills
  • Understanding of ICH and regulatory environment as it pertains to data management
  • Working knowledge of at least one EDC system (Rave preferred)
  • Working knowledge of industry data standards such as CDASH and SDTM
  • Experience in industry covering Phase I - Phase III studies
  • Experience with data visualization and integration systems such as Spotfire and Elluminate preferred
  • Technical background and skills including SQL and other analytics toolsets preferred

We offer a flexible work environment with 2-3 core collaboration days per week. The approximate salary range for this role is $194,000-$220,000.

Third Harmonic Bio is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.

", "lang_code": "en"}

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