Principal I, Clinical Data Management & Medical Intelligence

Looking at 7+ Years of experience in Clinical Data management.

Simultaneously leads trials as a Trial Data Manager for 4+ trials in parallel with minimal to no support.

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).  Overseas and ensures quality where support services are provided.

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

Performs DM maintenance and validation activities during the course of the study timely and with quality and overseas and ensures quality where support services are provided.

Ensures that Clinical Coding is performed at a consistently high standard in the Therapeutic Area/Franchisee. Ensures that the Coding related sections of the Data Management Documents are updated and Coding is complete and reviewed in support of all timelines/deliverables

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).  Represents Data Management at cross functional forums, meetings and provides timely feedback to partners

Responsible and accountable to ensure consistency of assigned trials with program level standards through technical implementation of Industry (CDISC and regulatory) Data Standards while acting as a technical consultant providing standards input to all relevant area data management and reporting areas.

Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution.

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

Understands Health Authority requirements and ensures adherence to GCP, standards, SOPs/procedures, job aids and guidelines, and is able to prepare for and participate in Health Authority inspections and audits as required

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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