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.

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