The Sr. Clinical Data Manager is responsible for managing all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support. The Senior Clinical Data Manager will ensure clean and valid clinical study data for delivery to biostatistics. This position coordinates activities with the Contract Research Organization (CRO), other external vendors, database programming and trial operations to define and implement data management requirements. This is a 6 month contract with possibility for perm.
Responsibilities Actively participates in multiple cross-functional teams to ensure the effective delivery of assigned project milestones. Work closely with CROs during the design and development of Electronic Case Report Forms (eCRFs), CRF Completion Guidelines (CCGs), Edit Checks and Data Management Plans (DMPs) Participate in UAT for each database build and work with vendor to understand the impact of all mid-study updates to the database. Facilitates and participates in data cleaning, via patient profiles and listings, on an ongoing basis. Suggest queries and report trends to the internal teams and CROs. Oversees the deliverables of external data management vendors for quality, completeness and adherence to timelines Manage and track database lock timelines and ensure CDM project milestones are met in coordination with the project team. Create and report data management updates to management on a regular basis; report on performance to plan Serve as data management resource to the clinical study team and data management team; assist in preparation of data for clinical study reports, documents for regulatory submission and help with submissions as directed. Support study-level audit and inspection readiness activities, as needed. Follow current SOPs.
Bachelor's degree in science/health- related area; or equivalent combination of education and experience Minimum 6 years of data management experience Working knowledge of industry standards, such asCDISC/SDTM Rave experience required Excellent communication and time management skills. Ability to effectively work on teams and independently Ability to prioritize study load and associated tasks Associated topics: data analyst, data architect, data integrity, data management, data quality, data scientist, data warehouse, etl, erp, mongo database