Stoke Therapeutics

Develops targeted gene upregulation therapies

Director, Clinical Data Management

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeBedford, MA, USA

About the Job

Requirements

A bachelor's degree or higher in a scientific or healthcare discipline; an advanced degree is a plus.
At least 10 years of progressive data management experience in biotech, pharmaceutical, or CRO settings, including prior line-management or people-leadership experience.
Proficiency in clinical data collection, cleaning, and analysis for Phase I–IV clinical trials in the pharmaceutical industry.
Experience working in an outsourced data management model.
Knowledge of electronic data capture databases, CDISC standards (CDASH, SDTM, and ADaM, including Define-XML), medical terminology, medical coding dictionaries (MedDRA and WHODrug), and quality control processes.
Working knowledge of GCP E6(R3), 21 CFR Part 11, and applicable FDA and EMA requirements, including risk-based quality management and ALCOA+ data integrity principles.
Ability to manage multiple initiatives and shifting priorities within a small-company environment.
Strong experience in early-phase drug development and rare diseases.
Proficiency with Microsoft Outlook, Word, Excel, PowerPoint, Project, and Visio.
In-depth knowledge of clinical data management systems such as Medidata Rave and Veeva Vault CDMS.
Approximately 5% travel is required.

Responsibilities

Lead data management activities for one or more development programs and serve as the highest escalation point for data management on assigned programs.
Manage day-to-day data management operations and oversee contract research organization data management activities, including project management, vendor management, and coordination of internal reviews.
Oversee data management activities for one or more programs consisting of multiple clinical studies, including activities supporting ongoing clinical programs.
Manage the Data Management team and balance resources to ensure appropriate support for current and future organizational activities.
Manage budgets and expenses, including budget projections.
Support inspection readiness, quality compliance, and training initiatives related to Data Management.
Create Data Management standard operating procedures and standards to support development programs.
Develop the Data Management Plan across programs and maintain it throughout the study lifecycle to ensure it follows study design and requirements.
Review clinical research documents, including protocols, case report forms, reports, and statistical analyses.
Review clinical database and trial data specifications, including electronic case report form design, user requirements, edit rules and checks, query logic, and data validations.
Review Data Transfer Agreements between external data vendors and core laboratories.
Reconcile electronic data transfers from vendors to the sponsor.
Oversee contract research organization user acceptance testing and coordinate testing of electronic case report form builds and validation documents, including edit-check documents, issue logs, and user acceptance testing summary reports.
Maintain and track electronic data capture user management and other clinical databases across allocated clinical trials.
Ensure clinical data in electronic data capture systems is high quality and ready for database lock or unlock and freeze or unfreeze for statistical, interim, and final review, including data reconciliation and coding.
Oversee electronic clinical outcome assessment, including eDiary, ePRO, ClinRO, and ObsRO, wearable and sensor data, and other electronic data collection methods, ensuring collection design meets scientific objectives.
Assist in defining or creating data listings, summary-table validation, and data specifications, and process data transfers in preparation for statistical review or data management audits.
Perform close-out audits as specified when closing a study in electronic data capture or other clinical data management databases.
Assist in reconciling adverse event and serious adverse event data in safety databases or other data management databases.
Coordinate and communicate consistently with database vendors to address clinical team requests, project plans, and electronic case report form development activities.
Participate in preparing and presenting data when applicable.
Ensure data-system compliance with national and international regulatory authority guidelines; identify and troubleshoot operational problems, issues, obstacles, and barriers, and work with appropriate teams to resolve them.
Establish and oversee a risk-based quality management approach to clinical data, including defining and continuously monitoring Key Risk Indicators and Quality Tolerance Limits in line with ICH E6(R3).
Drive data-driven oversight through centralized monitoring, data analytics, and review dashboards or metrics such as Spotfire, Power BI, and J-Review to detect anomalies, outliers, and trends across studies.
Ensure data integrity and 21 CFR Part 11 compliance across electronic data capture and external data sources, applying ALCOA+ principles and current computer system validation or assurance expectations.
Promote standardization and automation using tools such as SAS, R, or Python, and evaluate emerging AI- and machine-learning-enabled tools to improve the efficiency, consistency, and quality of data review and reporting.

Desired Qualifications

Rare disease and neurology trial experience is highly desirable.
Prior experience filing a Biologics License Application or New Drug Application.
Working familiarity with data review, visualization, and analytics tools such as SAS, R, Python, Spotfire, Power BI, J-Review, or elluminate.

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 Executive Director, Clinical Data Management 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 consistent basis to address. Clinical team’s requests, project plans, and/or eCRF development activities.
Participates in the preparation and presentation of data, when applicable.
Ensure data system compliance by following the established guidelines of national and international regulatory authorities. Helps to identify and troubleshoot operational problems, issues, obstacles, and barriers for studies and programs; Working with appropriate teams towards action and ensuring resolution
Establish and oversee a risk-based quality management (RBQM) approach to clinical data, including the definition and ongoing monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) in line with ICH E6(R3).
Drive data-driven oversight through centralized monitoring, data analytics, and review dashboards/metrics (e.g., Spotfire, Power BI, J-Review) to detect anomalies, outliers, and trends across studies.
Ensure data integrity and 21 CFR Part 11 compliance across EDC and external data sources, applying ALCOA+ principles and current computer system validation/assurance (CSV/CSA) expectations.
Promote standardization and automation (e.g., SAS, R, or Python) and evaluate emerging AI/ML-enabled tooling to improve the efficiency, consistency, and quality of data review and reporting

Required Skills & Experience:

Bachelor’s degree or higher in a scientific or healthcare discipline (advanced degree a plus), with 10+ years of progressive experience in data management within biotech, pharmaceutical, or CRO settings, including prior line-management / people leadership experience. Rare Disease and Neurology trial experience are highly desirable.
Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in the pharmaceutical industry
Experience working in an outsourced data management model
Knowledge of and experience with EDC databases CDISC standards (CDASH, SDTM and ADaM, including Define-XML), medical terminology, medical coding dictionaries (MedDRA, WHODrug), and quality control processes
Working knowledge of GCP E6(R3), 21 CFR Part 11 and applicable FDA/EMA requirements, including risk-based quality management and data integrity (ALCOA+) principles
Prior experience filing a BLA or NDA preferred
Ability to manage multiple initiatives and shifting priorities within a small company environment.
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
Strong experience in early phase drug development and rare diseases required
Microsoft Applications (Outlook, Word, Excel, PowerPoint, Project, Visio)
In depth knowledge of clinical data management systems (eg: Medidata Rave Veeva Vault CDMS) required; working familiarity with data review, visualization, and analytics tools (e.g., SAS, R/Python, Spotfire, Power BI, J-Review, or elluminate)

Location(s):

This position is open to both hybrid and remote work arrangements. Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026.

Travel:

This position will require approximately 5% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $225,000 - $244,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:

https://www.stoketherapeutics.com/careers/

For more information, visit https://www.stoketherapeutics.com/.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.

About the Company

Stoke Therapeutics

Develops targeted gene upregulation therapies

Stoke Therapeutics develops therapies for severe genetic diseases caused by loss of function in a single gene, aiming to restore missing proteins by upregulating protein expression. Its main product approach relies on the TANGO (Targeted Augmentation of Nuclear Gene Output) platform, which delivers precise, durable, and controllable upregulation of gene expression across a range of tissues to re-create the missing protein. Compared with many biotech firms, Stoke centers on upregulating endogenous gene output rather than replacing genes or adding new ones, and focuses on disease-modifying treatments for rare disorders with unmet medical needs. Revenue comes from partnerships, licensing agreements, and, ultimately, commercialization of its therapies. The company’s goal is to provide targeted, durable treatments that address the underlying genetic deficiency and improve outcomes for patients with limited options.

Company size: 201-500
Company stage: IPO
Headquarters: Bedford, TX
Founded: 2014

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