Sr Clinical Data Manager

Provides DM leadership across assigned trial(s) (4 or more).  Acts as the Trial Data Manager where needed for 2-3 studies in parallel.

Demonstrates a business understanding of the portfolio, products and indication to identify and assist in successful application of data management processes

Provides feedback to assure well-written protocols. Recognize and resolve protocol issues that may impact database design, data validation, data integrity and/or analysis/reporting while making the best use of standards and best practices

Leads the team through database build requirements, timelines and complete startup activities for study including: building the eCRF, completion guidelines, standard and simple rules, data validation plan and user acceptance testing (UAT)

Set up and manages external data in accordance with protocol requirements, process and validation requirements

Performs DM maintenance and validation activities during the study timely and with quality.

Tracks and reports status and progress for assigned trials and projects. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).

Effectively communicates status updates and study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)

Responsible and accountable to ensure consistency of assigned trials with program level standards through technical implementation of Industry (CDISC and regulatory) Data Standards, providing support to business users and teams on their use and supporting the implementation of the Clinical Data Standards strategy.

Mentors and assists Junior team members.

Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence

Ensures adherence to GCP, DM standards, SOPs/procedures, job aids and guidelines

Maintain up-to-date, knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.

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