Clinical Trial Support Specialist, Line Lead T500-15711
3 weeks ago
Position Summary / Objective : Manage a team that Reconciles and Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs Position Responsibilities: - 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. Degree Requirements: - Minimum of a Bachelor's degree in a scientific or related discipline, advanced degree preferred Experience Requirements: - 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. Key Competency Requirements: - 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. #HYDDD #LI-Hybrid
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeManage 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.-...
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Hyderabad, Telangana, India Bristol Myers Squibb Full timeManage a team that Reconciles and Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programsSupervisory 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...
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