Director, Clinical Data Management

About this role

About Stoke:

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose:

The Director of Clinical Data Management will be responsible for leading data management activities for one or more development programs and serves as the highest point of escalation within Data Management per assigned programs(s). This role will report to the VP Clinical Operations and be accountable for managing day-to-day operations of data management activities. The candidate will be responsible for oversight of Contract Research Organization (CRO) activities related to data management, including project management, vendor management, and coordination of internal reviews. Consistent with ICH E6(R3), the role champions a risk-based, quality-by-design approach to data management and data governance across the portfolio.

Key Responsibilities:

• Accountable for data management activities for Stoke clinical studies and oversee CRO data management activities that support ongoing clinical programs.

• Oversee data management activities for one or more product/programs, consisting of multiple clinical studies

• Manage a best in class Data Management team, consisting of highly qualified and experienced data managers

• Balance resources, and ensure appropriate levels to support organization activities (current and future)

• Manage budgets and expenses, including budget projections

• Support inspection readiness, quality compliance, and training initiatives pertaining to Data Management activities

• Create SOP’s and standards for Data Management to support Stoke’s development programs

• Develop 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.

• Review clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis).

• Review DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.

• Review Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.

• Reconcile electronic data transfers from vendor to Sponsor.

• 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.

• Accountable for eCOA (eDiary/ePRO/ClinRO/ObsRO), wearable and sensor data, and other electronic data collection methods to make sure the design of data collection meets the scientific objective.

• 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 con