Position Overview:The Sr. Clinical Data Manager is responsible for data management operations and for the organization, coordination and execution of data management activities for assigned studies and projects. This includes but is not limited to database set-up (build, develop, and perform user acceptance testing), development of study documents, training, data review, query generation and resolution, and overall maintenance of study databases to ensure data integrity from study start-up to database lock. This also includes data support for department projects, and inquiries, unrelated to clinical studies.
Responsibilities:- Lead, manage, execute end-to-end data management activities for clinical trials conducted inhouse or outsourced to CRO's.
- Develop and maintain Data Management Plans (DMPs), CRFs, edit check specifications, and other essential documents.
- Oversee database build.
- Testing, validation, and UAT processes in EDC systems
- Ensure timely and high-quality data collection, cleaning, reconciliation, and database lock activities.
- Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendors.
- Ensure data integrity and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standards.
- Participate in and contribute to protocol development, case report form design, and data flow diagrams.
- Conduct and oversee data reconciliation, external data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD).
- Provide study specific reports and data listings on regular basis and for ad-hoc requests
- Support audit readiness and participate in regulatory inspections when required.
- Mentor junior team members and provide strategic input into department process improvements and SOP development.
Qualifications:
Required:- Bachelor's or Master's degree in Life Sciences, Data Science, Computer Science, or a related field.
- 7+ years of clinical data management experience, with at least 2 years in a senior or lead role.
- Experience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.).
- Strong understanding of EDC systems and data standards (CDASH, SDTM, CDISC).
- Knowledge of regulatory requirements (FDA, EMA, ISO 14155, GCP, GDPR).
- Excellent organizational, leadership, and communication skills.
Preferred:- Experience working in an FDA-regulated and/or ISO-certified environment.
- Advanced proficiency in data visualization tools and data analytics platforms (such as Python and/or R) is a plus.
