Associate Director, Clinical Data Management

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.  The person in 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. This role will be expected to work in a fast-paced environment, for a Rare Disease program, with creativity and innovation at top of mind.  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:

• Minimum of 6-8 years of experience clinical data management/clinical trials is required
• Minimum Bachelor’s degree in life science or related discipline required, advanced degree preferred
• Experience with complex study designs and matrix management of a high number of vendors processing clinical data within/across studies and programs
• Experience with rare disease is beneficial, FSHD/ dystrophies preferred
• Proficiency with technology associated with current and evolving data management practices, including electronic data capture, data aggregating, data visualization and analytics, automated data bots, machine learning/artificial intelligence-based process enhancements, etc.
• Project level experience as a clinical data manager (rare disease setting a plus) in an outsourced data management model
• Prior experience preparing submission materials and filing a BLA or NDA, including inspection readiness
• Proficient in clinical data collection/reporting/review and analysis processes using EDC platforms (i.e., Medidata, Veeva, ePRO,  etc.) for Phase I-IV clinical trials in pharmaceutical industry/clinical research company
• Knowledge of and experience with medical terminology, medical coding dictionaries (MedDRA, WHODrug), and quality control processes
• Knowledge of industry and regulatory standards (FDA and EMEA Regulations, ICH Guidelines, and GCP) including CDISC standards (CDASH/SDTM)
• Ability to contribute to improving the quality of internal data management policies, programs and initiatives
• Ability to work independently to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical development milestones
• Excellent interpersonal skills and communication skills (verbal and written) with the ability to work independently and collaboratively in a dynamic team environment
• Ability to thrive working in a fast-paced environment and manage a variety of projects simultaneously and handle rapidly changing information, where fearless innovation is a core value
• Ability to clearly communicate, resolve complex issues, and mitigate risks
• Embrace Dyne’s core values
• Excitement about the vision and mission of Dyne

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