Job Description

• ct as the point of contact for DM activities for the assigned clinical studies and proactively provide DM expertise to both internal and CRO cross-functional teams.
• ssist the head of data management in establishing standards for electronic Case Report Forms (eCRFs), edit checks, data listings and reports, and data metrics.
• Supervise and ensure all databases are developed, validated and ready for production release according to both Structure and CRO SOPs and working instruction.
• Facilitate database design by the CRO according to the protocol and also in line with Structure global standard library; lead and perform sponsor acceptance testing of the clinical database.
• Contribute to the development/review of all the DM documentations, including but not limited to CRFs, CRF completion guidelines, Data Management Plan, Edit Check Specification, Data Review Plan, Data Transfer Specifications, etc.
• Ensure the oversight activities are conducted by the internal study teams as specified in the study specific Data Quality Oversight (DQOP), and the observations are Plan documented on the study specific cumulative Data Issue Tracker, and the confirmation of resolution are properly documented.
• Participate in development of DM specific SOPs.
• Core Competencies, Knowledge, and Skill Requirements.
• Detail-oriented, thorough and well-organized.
• In-depth knowledge of FDA regulations, GCP, GCDMP, CDISC, 21CFR Part 11and ICH guidelines.

• BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields.
• 8+ years of clinical data management experience in pharmaceutical and/or CRO's
• Complex and international trial experience desired.
• Strong communication (written and oral), decision-making, influencing, and negotiation skills at all organizational levels.
• bility to work independently and effectively in a fast-paced and collaborative environment.
• Proficient in Medidata Rave and/or other EDC platform study builds and operation
• Experience working with and managing CROs/external vendors, 5+ years preferred
• Experience with regulatory inspection/audit preparation preferred..

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