Dyne Therapeutics Inc
Associate Director, Clinical Data Management
Dyne Therapeutics Inc, Waltham, Massachusetts, United States, 02254
Company Overview:
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). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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/studiesParticipate 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 documentsServe 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 processesOversee 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 membersProvide input into study protocols, SAPs, and other clinical documents, to ensure quality data collection and managementMap data flows, processes and systems used for collection, management and provision of data to downstream functional area usersContribute 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 databaseMeet 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 measuresContribute to the development of data management standard working practices along with preparations and requirements for regulatory submissions and inspectionsEstablish data transfer guidelines for external data with CRO and vendor partners; reconcile and ensure transfers are executed to planReconcile electronic data transfers from external vendors (e.g., IXRS, specialty labs, etc.) to the sponsor and/or oversee study data reconciliations performed by the CROAssume ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating proceduresMaintain/track or oversee EDC user management and other Clinical databases across allocated Clinical trialsCoordinate 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 issuesAssist in defining data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management auditsSupport close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBsContribute to data system compliance by following the established guidelines of national and international regulatory authoritiesEducation and Skills Requirements:
Minimum of 6-8 years of experience clinical data management/clinical trials is requiredMinimum Bachelor's degree in life science or related discipline required, advanced degree preferredExperience with complex study designs and matrix management of a high number of vendors processing clinical data within/across studies and programsExperience with rare disease is beneficial, FSHD/ dystrophies preferredProficiency 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 modelPrior experience preparing submission materials and filing a BLA or NDA, including inspection readinessProficient 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 companyKnowledge of and experience with medical terminology, medical coding dictionaries (MedDRA, WHODrug), and quality control processesKnowledge 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 initiativesAbility to work independently to manage multiple projects in a fast-paced environmentAbility to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical development milestonesExcellent interpersonal skills and communication skills (verbal and written) with the ability to work independently and collaboratively in a dynamic team environmentAbility 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 valueAbility to clearly communicate, resolve complex issues, and mitigate risksEmbrace Dyne's core valuesExcitement about the vision and mission of Dyne
#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.
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). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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/studiesParticipate 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 documentsServe 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 processesOversee 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 membersProvide input into study protocols, SAPs, and other clinical documents, to ensure quality data collection and managementMap data flows, processes and systems used for collection, management and provision of data to downstream functional area usersContribute 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 databaseMeet 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 measuresContribute to the development of data management standard working practices along with preparations and requirements for regulatory submissions and inspectionsEstablish data transfer guidelines for external data with CRO and vendor partners; reconcile and ensure transfers are executed to planReconcile electronic data transfers from external vendors (e.g., IXRS, specialty labs, etc.) to the sponsor and/or oversee study data reconciliations performed by the CROAssume ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating proceduresMaintain/track or oversee EDC user management and other Clinical databases across allocated Clinical trialsCoordinate 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 issuesAssist in defining data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management auditsSupport close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBsContribute to data system compliance by following the established guidelines of national and international regulatory authoritiesEducation and Skills Requirements:
Minimum of 6-8 years of experience clinical data management/clinical trials is requiredMinimum Bachelor's degree in life science or related discipline required, advanced degree preferredExperience with complex study designs and matrix management of a high number of vendors processing clinical data within/across studies and programsExperience with rare disease is beneficial, FSHD/ dystrophies preferredProficiency 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 modelPrior experience preparing submission materials and filing a BLA or NDA, including inspection readinessProficient 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 companyKnowledge of and experience with medical terminology, medical coding dictionaries (MedDRA, WHODrug), and quality control processesKnowledge 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 initiativesAbility to work independently to manage multiple projects in a fast-paced environmentAbility to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical development milestonesExcellent interpersonal skills and communication skills (verbal and written) with the ability to work independently and collaboratively in a dynamic team environmentAbility 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 valueAbility to clearly communicate, resolve complex issues, and mitigate risksEmbrace Dyne's core valuesExcitement about the vision and mission of Dyne
#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.