job title: clinical trial support specialist(CTMS & Veeva vault)

• Position Responsibilities

• In conjunction with the Submission Manager, and use of technologies, simplify the end-to-end process for Clinical Trial documents, maintenance and submissions

• Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs.

• Partners with the Submission Manager for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents.

• Ensures documents are formatted appropriately and Submission Ready Compliant (SRC)

• In collaboration with out outsourced partners, creates site numbers for new and ongoing clinical trials.

• Enters site milestones and regulatory approvals dates to maintain the quality health of the trail assigned to.

• Ensures Drug shipment address are entered correctly, and feed to SAP to enable IP Supply to sites.

• Performs a reconciliation of Veeva (eTMF/CTMS) to ensure accurate data is available and reflecting correctly.

• Proactively analyzes and drives efficient problem solving within team's control.

• Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items.

• Demonstrates thorough knowledge of relevant BMS SOPs and policies and the ability to provide timely guidance in their application to Protocol and/or Program teams. Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to submission deliverables where applicable.

• Demonstrates strong project management skills

• Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e.g. Core Template).

• Demonstrate understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.

• Manages interactions with senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents.

• Other duties as assigned to support Clinical Trials.

• Performs other tasks as assigned.

Experience Requirements

• 2-4 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field.

• Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma.

• Experience in the use of industry Clinical Trial Master File Systems or equivalent. Experience with Veeva Vault Clinical preferred

• Experience with MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies.