Stoke is seeking an enthusiastic, motivated Sr Clinical Data Manager. The candidate will oversee execution of data management activities for assigned clinical trial(s) and contribute to overall clinical study data strategy and planning. In close collaboration with Clinical Operations Trial Lead(s), will ensure compliance with quality standards (including ICH GCP, local and federal regulations and Stoke SOPs), within approved timelines and budgets. This position will report into the Director, Head of Clinical Data Management.
- Responsible for oversight of data management activities performed by CRO’s and third-party vendors to ensure timely execution of studies in assigned clinical program(s) in addition to compliance with quality standards (including ICH GCP, 21CFR Part 11, local regulations and Stoke SOPs).
- Responsible for leading all data management related activities from protocol synopsis through database lock and submission.
- Provide input into clinical study protocols, informed consent forms (ICFs) and other clinical trial documents as required
- Responsible for review and approval of all Data Management related documentation (DMP, Data validation and transfer specs etc).
- Support timely and efficient database lock by participating in data review / reconciliation efforts.
- Manage and assist in analysis and review of clinical data deliverables for publications, meetings, regulatory submissions, interim analysis and quarterly data review meetings.
- Provide EDC super user expertise, management of study URL’s and provide ongoing database training for new staff.
Represents data management function at the Clinical Study Team (CST) level and participate in vendor project team meetings as SME to ensure expectations are aligned between the CRO and Stoke for all data related data deliverables and associated timelines.
- Write and review work instructions and SOPs for data management activities Provide and enable solutions for complex problem solving that align with the Stoke values.
- Lead cross-functional Data Communication Planning meetings
- Lead and manage internal Data Review meetings
- Collaborate with project managers and team members to help determine data strategy for clinical trials to ensure high quality data
Required Skills & Experience:
- BS degree in Life Science, math, computer science or another related field required.
- 8-10 years of progressive clinical data management experience within biotech, pharmaceutical, CRO industry.
- Proven track record of strong project management skills and experience managing data management activities for small – large drug development programs
- Ability to handle multiple development programs simultaneously.
- Good understanding of CDISC standards, and experience implementing standards
- Strong knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
- Thorough command of FDA and ICH GCP regulations and industry standards applicable to clinical data management systems and 21 CFR Part 11 requirements
- Vendor management and oversight experience
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Rare Disease and Neurology trial experience are highly desirable.
- Proficiency in Microsoft Word, MS Project, Excel, and Outlook, PowerPoint, and MS Project
- Strong written and verbal communication skills
- SAS or alternative programming experience desirable
- Proficiency with data visualization tools desirable
- Proven track record of strong project management skills and experience managing data management activities for large drug development programs ·
- Experience with all phases of development
- Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. ·
- Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.
This position is based in Cambridge, MA.
This position will require 10-15% travel.
Benefits & Compensation:
Stoke Therapeutics offers comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Primary Caregiver Leave; a 401K program with company match, and an Employee Stock Purchase Program (ESPP). Compensation will be highly competitive for the industry and directly commensurate with experience.