About This Role
Hybrid role based at Headquarters in Cambridge, MA.
Responsibilities
- Oversee CRO data management activities by reviewing deliverables, timelines, and resolving issues.
- Generate clinical data reports, listings, and summaries using programming tools.
- Fulfill internal ad hoc data requests and analyses for stakeholders.
- Monitor data quality and database readiness; coordinate needed revisions.
- Partner with cross-functional stakeholders on data deliverables and issue resolution.
- Collaborate on study data strategy, data review priorities, and CRO oversight.
- Coordinate data cleaning priorities and query management with external vendors.
- Support protocol deviation assessment and documentation quality.
- Resolve quality issues impacting compliance or data integrity.
- Provide data outputs/analyses for regulatory submissions and safety reviews.
- Review study progress and operational issues impacting data quality and interpretation.
Required Skills/Qualifications
- Bachelorβs degree with at least 5 years of experience in clinical data management (or related).
- Proficiency generating data outputs using SAS, Python, and advanced Excel (Power Query or similar).
- Experience overseeing CRO data management activities.
- Strong analytical/problem-solving skills.
- Excellent communication and collaboration.
Preferred Skills
- Advanced degree.
- Experience with implantable devices and Class III medical device studies.
- Familiarity with regulatory submissions and protocol amendments.