Expires soon SANDOZ

Sr. Clinical Data Manager, Oncology Data Sciences, BDM

  • East Hanover (Morris County)
  • IT development

Job description

Job Description

Provide leadership for project related Data Management activities of drug development such as Clinical Study conduct including Case report form (CRF) design, CRF Completion guideline (CCGs), Clinical Protocol review, clinical database build up, data collection, edit checks, medical coding, Serious Adverse Event (SAE) reconciliation, database locks, and archival of Data Management deliverables and documents. Participate in the review of Clinical research documents like Protocols, specifically related to Visit evaluation schedule, study design and Data Management section and ensure consistency of protocols, Validation and Analysis Plans, (VAPs) & Project eCRFs for all trials within assigned projects. Support Clinical Trail Head in ensuring all trial deliverables are met according to timelines, cost, operational procedures and quality standards. Assigned responsibilities include development of study tools, guidelines and training materials; management of clinical study material; implementation of issue resolution plan. Responsible for ensuring that clinical data is validated according to the Data Handling Plan (DHP) and Data Review Plan (DRP) and are ready for interim and final deliverables by providing clean and consistent data. Provide timely and high quality completion of Data Management deliverables according to established objectives, including: Validation and Analysis Plans (VAP), Case report form (CRF) Design, User acceptance testing (UAT) of eCRF. Reports status and progress for assigned trials and is proactive to ensure smooth and successful timely snapshots and interim/final locks. Facilitate constructive collaboration within drug development teams Global Program Team (GPT)s, etc.) and with other internal partners Accountable for accuracy of trial information in all trial databases and tracking systems. Support trial data analysis, reporting and publishing. Apply business understanding of the compound profile to identify and assist in successful application of data management processes. Lead and participate in the ongoing review of all data generated from the clinical study including central and local lab data and coding. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Desired profile

Minimum requirements

Candidate must have a Master’s or foreign equivalent degree in Computer Science, Life Science, Pharmacy or related relevant field and 3 years’ experience in drug development and clinical data management. Must have experience in: the management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for assigned trials; Data Management leadership across one or multiple trials; leading study start-up activities such as preparing the electronic Case Report Forms (eCRFs), Case Report Form Completion Guidelines (CCGs), DHPs, DRPs and performing User Acceptance Testing (UAT); the review of Clinical research documents like Protocols, specifically related to Visit evaluation schedule, study design and Data Management section.

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