Job Title: Clinical Trial Support Specialists, Line Lead
Location: Hyderabad, Telangana, India
Company Overview:
Bristol Myers Squibb (BMS) is committed to transforming patients' lives through science. At BMS, challenging, meaningful, and life-changing work happens daily, across various departments. With a focus on growth and development, BMS provides a supportive and inclusive work environment where employees have the chance to make significant impacts.
Job Description:
The Clinical Trial Support Specialists, Line Lead role involves overseeing a team responsible for reconciling and preparing clinical trial submission documents, ensuring compliance with regulatory guidelines. This position requires managing both in-house and outsourced clinical trials, supporting Clinical Trial Management Systems (CTMS) activities, and ensuring consistency across the team.
Key Responsibilities:
Leadership & Team Management:
Lead and supervise the Clinical Trial Support Specialists (CTSS) team, ensuring consistent and high-quality work.
Oversee CTSS activities, ensuring adherence to ICH/GCP guidelines and regulatory requirements.
Prioritize and allocate tasks across the team based on project demands.
Provide leadership, infrastructure, and expertise to study teams and CROs.
Manage interactions with senior multifunctional teams, ensuring smooth operations for submission documents.
Collaboration & Continuous Improvement:
Collaborate across functions to ensure compliance with regulatory requirements for CTMS administrative appendices and other documents.
Identify opportunities for process efficiency and improvement.
Lead and contribute to continuous improvement initiatives related to clinical trial documentation.
Regulatory & Technical Expertise:
Stay informed about regulatory requirements and industry trends related to regulatory submissions.
Ensure the team's documents are compliant with regulatory and ethical standards.
Demonstrate in-depth knowledge of Clinical Trial Management Systems, specifically Veeva Vault, and document management systems.
Skills & Qualifications:
Education: A Bachelor’s degree in a scientific or related field (advanced degree preferred).
Experience: 5-7 years in the health sciences or related industry, with supervisory responsibility.
Strong understanding of GCP, ICH, and regulatory guidelines as they apply to clinical trial protocols.
Familiarity with Veeva Vault or other Clinical Trial Master File systems.
Proficiency in Excel, PowerPoint, SharePoint, and CTMS tools.
Excellent organizational, time-management, and communication skills.
Ability to manage complex issues and prioritize tasks in a fast-paced environment.
Additional Information:
The role is hybrid (on-site and remote options available).
BMS Benefits: Offers a variety of competitive benefits, including health benefits, time off, and recognition programs.
Why BMS?:
At BMS, employees have the opportunity to grow within a collaborative environment, working on projects that transform the lives of patients worldwide. BMS is committed to fostering diversity, inclusion, and equal opportunities for all employees.
This position offers a unique chance to lead a team in the dynamic clinical trial space, contributing to innovative drug development.
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