Senior Clinical Data Manager

Precision's Data Management team is growing. We are looking for an experienced Senior Clinical Data Manager to join our European team. This position could be covered fully remotely from any of our locations : UK, Spain, Poland, Slovakia, Romania, Hungary or Serbia.

Position Summary

The Senior Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs / WIs); regulatory directives; study-specific plans and guidelines will be followed. This position will also oversee and / or perform database development and testing.

Essential functions of the job include but are not limited to :

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
• Provide input, assess and manage timelines. Ensure that clinical data management deadlines are met with quality.
• Develop CRF specifications from the clinical study protocol and coordinate the review / feedback from all stakeholders.
• Conduct database build UAT and maintain quality controlled database build documentation.
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Run patient and study level status and metric reporting.
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency.
• Coordinate SAE / AE reconciliation.
• Liaise with third-party vendors such as external data and EDC vendors in a project manager capacity.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) related to data management.
• Provide leadership for cross-functional and organization-wide initiatives.
• Communicate with study sponsors, vendors and project teams as needed regarding data-related project issues.

Qualifications

Minimum Required :

Other Required :

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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