Clinical Trial Support Specialist

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 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 teams 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.

Qualifications / Requirements

• Minimum of a bachelor's degree in Life science.
• BS/BA Degree with approximately 4 years of pharmaceutical or biotech experience in a clinical drug development setting, of which at least 2 years should be in the pharmaceutical, biotech or CRO environment. Advance degree a plus.
• 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.
• Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
• Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.
• Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
• Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
• Ability to sustain high levels of performance in a constantly changing environment.
• Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
• Ability to prioritize work and assess risk to meet the needs of the organization.
• Demonstrated ability to work independently and seek out support when needed.
• Proactive, adaptable and able to modify personal and organizational work style to meet the needs of the business.
• Strong understanding of protocol-related documents, and document management systems (e.g. Core Template).
• Ability to manage complex issues and proactively apply critical thinking to address challenges. Some positions may require experience in a specific therapeutic area.
• Exceptional written and oral communication skills.