Clinical Data Manager in Cambridge, MA

Interact both verbally and through written communication with inter-organizational and outside customer contacts as well as with Central and External laboratories, CROs, etc. -Contribute to the design of protocols -Develop eCRF specifications according to protocol and approved standards (based on industry standards), participate in user acceptance testing -Develop protocol specific edit check specifications, participate in user acceptance testing -Develop and maintain project- specific Data Management plan throughout the life-cycle of the study protocol, which includes CRF annotation, database specifications, edit checks and other pertinent data management documents -Provide training for team members in data management procedures -Prioritize tasks with respect to pre-determined timelines -Provide direction and coordinate data management activities to ensure timely database lock and release of data for interim and final analyses -Provide oversight, monitor and track quality of vendor data management deliverables, ensuring audit practices are in place to validate the quality of EDC database content as well as external electronic data transfers -Perform metrics on data management processes and guidelines to evaluate efficiency, accuracy, and speed in cleaning clinical study data and locking database for study reporting -Ensure data processing activities are performed according to protocol, GCP and SOPs -Participate in hands-on data review and query management as necessary.

Required:

• Thorough understanding of database concepts
• Ability to adapt and be flexible to change and managing internal and external impediments
• Experience in managing and leading international meetings (Data Review, etc)
• Strong Vendor Management skills
• Ability to handle multiple tasks and to prioritize, strong organizational and presentation skills
• Strong interpersonal and communication skills (verbal and written)
• Project Management skills
• Knowledge and qualification with international standards (e.g. GCP, CDISC/CDASH, etc.), EDC (e.g., Medidata Rave), processes and SOPs
• Ability to work in an international environment with internal and/or external partners (CROs, etc.)
• Familiarity with standard international coding dictionaries (e.g., WHODD, MedDRA).
• Knowledge of industry data management standards and practices

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