Our commitment to people with muscle diseases
is our greatest strength

Senior Director, Clinical Data Management

Department: 121 Clinical Operations

Location: Waltham, MA

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary

The Senior Director, Clinical Data Management will be accountable for global delivery, integrity, and quality of Dyne’s clinical data across the portfolio. The candidate will provide leadership, direction, and expertise to the clinical data management function. This position will serve as the in-house data management expert, provide consultation to all functions, and be responsible for building a data management team to support the Dyne clinical portfolio. This position will also have strategic responsibility for oversight of Contract Research Organization (CRO) activities related to data management, including project management, vendor management, and coordination of internal reviews.

This role reports to the Head of Clinical Operations and is based in Waltham, MA without the possibility of being a remote role. 

Primary Responsibilities Include:

  • Lead the data management function at Dyne and oversee CRO data management activities that support ongoing clinical programs
  • Provide leadership of evolution and improvement of data processes and procedures (e.g., SOPs), policies, systems and organization in alignment with other development functions
  • Facilitate resource forecasting and allocation for multiple programs; grow and scale a strong data management team
  • Continuously enhance the team’s clinical and technical expertise and business acumen
  • Lead and/or oversee the development of the Data Management Plan (DMP) across programs and maintain throughout lifecycle of study project to ensure DMP is followed according to study design and requirements
  • Responsible for all Data Management timelines and quality of data deliverables in collaboration with other functions
  • Provide input to and review clinical research documents (e.g., Protocols and Statistical Analysis Plans)
  • Lead EDC and IRT database (DB) specification process internally
  • Drive the review/development of clinical trial database specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations
  • Lead the development and review of Data Transfer Agreement(s) (DTAs) and oversee the data integrations between external vendors using/generating study data
  • Reconcile electronic data transfers from external vendors (e.g., IXRS, specialty labs, etc.) to the sponsor and oversee study data reconciliations performed by the CRO
  • Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to, edit check document, issue logs, UAT summary report
  • Maintain/track EDC user management and other Clinical databases across allocated Clinical trials
  • Ensure clinical data within EDC is of high quality to support lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to, data reconciliation and/or coding
  • Devise or oversee development of data metrics, trending and reports for data review meetings with appropriate internal stakeholders to ensure ongoing data integrity and proactive identification of data issues
  • Accountable for eDiary, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective
  • Manage data system updates and change controls, implementation and re-qualification, including conducting prior impact assessments
  • Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
  • Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs
  • Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB
  • Coordinate and communicate with DB vendors on consistent basis to address study/program team's requests, project plans, and/or eCRF development activities
  • Participate in the preparation and presentation of data, when applicable
  • Ensure data system compliance by following the established guidelines of national and international regulatory authorities

Education and Skill Requirements:

  • Bachelor's degree or higher, preferably in a scientific area or health related discipline. Advanced scientific or business degree or equivalent desirable
  • 10+ years of clinical data management leadership experience in pharma/biotech
  • Experience with complex study designs and matrix management of a high number of vendors processing clinical data within/across studies and programs; experience with pediatric and/or rare disease is beneficial
  • Proficient in clinical data collection, cleaning, and analysis for Phase I-IV clinical trials in a pharmaceutical industry/clinical research company
  • Experience working in an outsourced data management model
  • Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
  • Familiarity with GCP, ICH and FDA and other regulatory requirements as applicable for clinical data management
  • Prior experience filing a BLA or NDA preferred
  • Demonstrated leadership in a cross-functional team setting
  • Ability to manage multiple initiatives and shifting priorities within a small company environment
  • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
  • Experience with hiring, managing, mentoring and/or developing direct reports preferred

#LI-Onsite

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.


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