We are seeking multiple Senior Clinical Data Scientists responsible for providing timely & ongoing management of data, coding, CDDRA-database development, and DAP deliverables and for clinical trial data with respect to cost, quality, and timelines for all assigned trials within Clinical Data Management.
Ensure consistently high-quality data is available for analysis and reporting.
Develop content and redesign training modules into engaging & interactive applications, leveraging technology to simplify processes and enhance training delivery.
Follow Good Clinical Practices (GCP), data-handling procedures, and guidelines.
Participate in the review of clinical research protocols, reports, and statistical analysis plans.
Key Responsibilities
Provide DM leadership across assigned trials and act as Trial Data Manager where needed.
Demonstrate business understanding of compounds to identify and assist in the successful application of data management processes.
Provide feedback to assure well-written protocols and amendments.
Recognize and resolve protocol issues that may impact database design, data validation, and/or analysis/reporting.
Perform DM activities for startup of a study: Data Handling Plan, Data Review Plan, and user acceptance testing (UAT).
Manage local lab set-up for the clinical database as applicable.
Lead process and training deliverables within platforms or processes.
Accountable for all aspects of process and training to ensure full compliance with global regulatory requirements and business objectives.
Centralize and align DO for audits and inspections, manage and measure quality, and coordinate exception requests, deviations, and corrective/preventive action plans.
Perform DM hands-on activities during the course of the study.
Perform ongoing review of all data generated from the clinical study, including third-party and local lab data, as well as SAE reconciliation where applicable.
Ensure consistency of assigned trials with program-level standards across DM documentation.
Use available tools to generate listings for data review and provide them to study teams.
Generate study status reports for use at clinical trial team meetings.
Support and assist junior staff on assigned trials.
Provide effective input into DM initiatives and innovations for quality, efficiency, and continuous improvement.
Lead/coordinate synonym review activities and dictionary version upgrade activities at the trial/program level.
Serve as primary study lead, ensuring timely and quality deliverables by establishing and maintaining strong working relationships with study teams and functional lines.
Act as a technical consultant as required.
Lead DAP activities for assigned/project-level activities for phase I to IV clinical studies.
Lead independently or participate in improvement initiatives and/or nonclinical projects.
Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
Minimum Requirements
Degree/Master's qualified in a relevant area.
At least 4 years of experience in Clinical Data Management within drug development.
Experience working across several end-to-end studies.
Strong collaboration and organizational skills with proven ability to manage simultaneous trials and meet deadlines.
Excellent understanding of clinical trials methodology, GCP, and medical terminology.
Proven ability to interrogate and view data through various programming/GUI techniques.
Commitment to Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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