What are the responsibilities and job description for the Associate Director, Clinical Data Management position at Dyne Tx?
Our commitment to people with muscle diseases is our greatest strength.
The following information provides an overview of the skills, qualities, and qualifications needed for this role.
Associate Director, Clinical Data Management
Dyne Therapeutics is a clinical-stage muscle disease company focused on 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. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary :
The Associate Director, Clinical Data Management supports the Head of Data Management by providing expertise in all aspects of clinical data management for assigned study(ies). The person in this role will participate with both strategic and hands-on support, oversight of vendors / CROs, and contributions to departmental process and standards development. This role will manage all data management (DM) tasks for a clinical program from study startup through database closure and archival, producing high-quality databases for analysis and potential regulatory submissions. The person in this role must have experience in a regulated environment and be prepared to present data and documentation in support of regulatory requirements for complete and accurate data. This role works closely with cross-functional members of the study team including Clinical Development, Biostatisticians, Statistical Programmers, Pharmacovigilance, Regulatory, Translational Research, and Clinical Operations. This role is based in Waltham, MA without the possibility of being a remote role.
Primary Responsibilities Include :
- Provide representation, and guidance to the internal and external teams as the clinical data management subject matter expert for assigned program / studies.
- Participate in process improvements within data management by authoring, reviewing, publishing, and reviewing policies and methods in standard operating procedures, work instructions, job aids, and other training documents.
- Serve as a subject matter expert for various operations, including, but not limited to, electronic data capture, external data standardization, collection, and processing, and the creation of standard data collection forms and associated validation checks and collection processes.
- Oversee CRO data cleaning activities including processing queries, performing ongoing data review, identifying and tracking data issues and trends to give transparency to Global Development Program Leads, and other program team members.
- Provide input into study protocols, SAPs, and other clinical documents, to ensure quality data collection and management.
- Map data flows, processes, and systems used for collection, management, and provision of data to downstream functional area users.
- Contribute to data management deliverables including Data Management Plans, Data Validation Manuals, CRF Completion Guidelines, Data Transfer Specifications, Lab Specifications, etc.
- Support vendor UATs for database builds and or migrations to manage any impacts from mid-study updates to the EDC database.
- Meet with global regulatory agencies and mock auditors in quality, performance, and system audits and inspections and ensure inspections meet department performance metrics through pro-active compliance and quality measures.
- Contribute to the development of data management standard working practices along with preparations and requirements for regulatory submissions and inspections.
- Establish data transfer guidelines for external data with CRO and vendor partners; reconcile and ensure transfers are executed to plan.
- Reconcile electronic data transfers from external vendors (e.g., IXRS, specialty labs, etc.) to the sponsor and / or oversee study data reconciliations performed by the CRO.
- Assume ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans, and standard operating procedures.
- Maintain / track or oversee EDC user management and other Clinical databases across allocated Clinical trials.
- Coordinate with CRO on presentation of data metrics, trending, and reports for data review meetings with internal stakeholders to ensure ongoing data integrity and proactive quality measures are employed to identify data issues.
- Assist in defining data listings, summary table validation, data specifications and / or process data transfers in preparation for statistical review and / or data management audits.
- Support close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
- Contribute to data system compliance by following the established guidelines of national and international regulatory authorities.
Education and Skills Requirements :
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