Sr. Associate, Clinical Data Management & Medical Intelligence

Major Accountabilities

Provides DM support across multiple (4 or more) assigned trial(s). Acts as the Trial Data Manager for 1 trial in sequence where needed

Provides feedback to assure well-developed databases and data validation setup and execution while making the best use of standards and best practices

Supports the team through database build requirements and complete startup activities for study including: building the eCRF, completion guidelines, standard and simple rules, data validation plan and user acceptance testing (UAT); can lead a study in sequence under PCDM supervision.

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 Trial Data Manager (TDM) and Program Clinical Data Manager (PCDM)

Provides support to business users and teams on their use and supporting the implementation of the Clinical Data Standards strategy.

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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