Director, External Data & Systems

Role Summary:

The Director, External Data & Systems is accountable for developing quality systems for the collection, management and delivery of external (non-electronic data capture (EDC)) clinical data, including fluid & tissue labs, digital, imaging and wearables.  This role will develop a comprehensive strategy for assessing, monitoring and mitigating data collection issues to ensure delivery of high quality data.  The Director, External Data & Systems will partner cross functionally in Dyne, as well as with external vendors to implement this strategy at the study level.  This role will leverage expertise to lead this new capability and support all studies within Dyne’s clinical development programs.

In addition, this role will be accountable for operational management of Dyne data management systems implemented for data quality reviews and operational oversight.  This includes increasing user adoption, configuration of new studies as they are initiated, and development of custom reporting, through coordination with internal stakeholder functions and external service provider(s).

The Director, External Data & Systems will report to the Head, Data Management within the Data Analytics department, and will manage the Sr Manager, Clinical Data Analyst.  This role will also assist with other projects as dictated by the business.This role is based in Waltham, MA without the possibility of being fully remote.
 
Primary Responsibilities Include:

• Participating in vendor selection and vetting activities to assess vendor compliance with regulatory requirements for non-EDC data, and data collection risk
• Accountable for ensuring the design of external data collection meets the scientific objectives as per protocol and intended analyses
• Developing and manage Data flows for each study, for use developing data transfer controls, operational oversight and for inspections
• Developing Data Transfer Agreements/ Specifications for each data flow, coordinating with Dyne internal functions and vendors
• Coordinating assessments of data integrity or quality risks, for external data collections
• Developing a Data Quality Plan, including monitoring, reporting and mitigation strategies, for each external data collection and associated data integrity or quality risks
• Developing strategies for the automation of data transfer and monitoring processes
• Oversight of vendor transfers, coordinating with DM Leads, Dyne’s CRO(s), and Dyne functions that oversee vendors that deliver external data collections
• Accountable for oversight of reconciliations of external data to EDC systems and external data cleaning operations, working with Dyne Data Management Study Leads and clinical data analysts and vendors for delivery of high quality data during periodic data (interim cuts) and database locks
• Developing and monitoring external data vendor KPIs and metrics to inform study operations and vendor management
• Providing stakeholder functions and study teams with data management expertise for processes and technical system used in external data collection, including applicable regulatory requirements (GCP, ICH, EMA) and clinical data standards (e.g. CDISC CDASH, SDTM)
• Accountable for ensuring documentation is developed for external data operations and deliveries to satisfy inspection readiness requirements
• Oversight for Dyne clinical data management systems used for operational data reviews
• Accountability for gaining stakeholder input and requirements for custom reporting, for ongoing operational data reviews, and working with vendors for implementation
• Responsible for mentoring, developing and performance management of direct reports

Education and Skills Requirements:

• Minimum of 10+ years of experience clinical data management/clinical trials
• Bachelor’s degree in life science or related discipline required, advanced degree preferred
• Experience with hiring, managing, mentoring and/or developing direct reports
• 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 preferred
• Prior experience and demonstrated leadership in managing external data collections
• Demonstrated technical experience in developing data models, data flows, data transfers and external data monitoring
• Experience working in an outsourced data management model
• Prior experience in preparing materials in support of inspection readiness
• Prior experience filing a BLA or NDA preferred
• Knowledge of industry and regulatory standards (FDA and EMEA Regulations, ICH Guidelines, GCP, CDISC standards) applicable to external data
• Ability to successfully develop and implement data management programs and initiatives
• Excellent interpersonal skills and communication skills (verbal and written) with the ability to work independently and collaboratively in a dynamic team environment
• Experience presenting to senior management and program teams
• Ability to thrive working in a fast-paced environment, manage a variety of projects simultaneously, and handle rapidly changing information
• 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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