job title: clinical trial support specialist(bms)

Manage a team that Reconciles and Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs

• Supervisory responsibility for Clinical Trial Support Specialists, providing support of the in house and outsourced studies in support of CTMS activities to ensure consistency across the team.

• Oversee CTSS activities to ensure compliance with ICH/GCP Guidelines, regulatory requirements.

• Provides leadership, infrastructure, and subject matter expertise to the Study teams and CRO’s.

• Prioritizes book of work for CTSS team and assign resources based on priority projects.

• Collaborates across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements for CTMS administrative appendices and other regulatory documents.

• Identify efficiency opportunities to streamline process.

• Maintains continuous knowledge of the regulatory requirements and industry trends related to regulatory Submissions

• Communicate as appropriate with relevant stakeholders

• Leads and participates in continuous improvement initiatives related to clinical trial documentation.

• Must be competent in Project Management tools and methodologies.

• Excellent organizational and time management skills

• Technical expert and able to further develop KPIs and metrics.

• Strong analytical, problem-solving, and critical thinking skills

• Must be able to interact and communicate effectively at all levels of the organization

• 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.

• Performs other tasks as assigned.

• Minimum of a Bachelor’s degree in a scientific or related discipline, advanced degree preferred

• At least 5-7 years of experience in health sciences or related industry Supervisory responsibility, provides training, support, and coaching as require.

• Strong working knowledge of Clinical Trial Managements Systems preferably Veeva Vault.

• Strong organizational and technical ability.

• Demonstrated Excel, PowerPoint, and SharePoint skills.

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

• Strong understanding of GCPs, ICH and regulatory regulations and guidelines as they apply to protocol management and program strategy.

• Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.

• 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.