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Director, Clinical Data Management

Cambridge, Massachusetts, United States

About Third Harmonic Bio

Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation – debilitating conditions that can take a significant toll on overall health and well-being.

We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases.  Despite the availability of multiple approved medicines, there is an urgent need for new treatment options.  We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.

We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.

Our Values

Our values provide the foundation for our culture and our operating principles – and underly how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.

Be Human

Relationships are important.  Bring your full self to work and create space for others to do the same.  Balance candor with empathy.

 

Own the Big Picture

Context is critical.  Ground every decision and action in the entirety of what we are trying to achieve.

 

Go THRD

We hold ourselves to a higher standard.  Work with urgency, purpose, and passion.

 

The Role

Reporting to the Senior Director, Clinical Data & Systems, the Director of Clinical Data Management is accountable for all aspects of the clinical trial data management process from study start up to database lock. This person drives end-to-end study data quality and integrity by providing oversight of contracted Clinical Research Organizations (CROs) and being a collaborative member of the study team.  This is an exciting time to join THRD; as we grow, this role will be empowered to influence the design of study data collection, data management and how the data is shared. 

Responsibilities

  • Lead Data Management (DM) contact and contributor for Third Harmonic Bio clinical studies
  • Serves 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

Minimum Qualifications

  • Bachelor’s degree in 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 have a flexible work environment, with 2-3 core collaboration days per week

The approximate salary range for this role is $194,000-$220,000.

All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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