Job Title: eTMF Specialist
Company: Bristol Myers Squibb
Location: Hyderabad, TS, IN
Job Type: Full-time
Are you looking for a challenging and rewarding career opportunity in the pharmaceutical industry? Do you have a passion for clinical trial documentation management and a desire to make a difference in the lives of patients? Look no further than our eTMF Specialist role at Bristol Myers Squibb.
About Us
Bristol Myers Squibb is a leading biopharmaceutical company that is committed to transforming patients’ lives through science. Our company has a long history of innovation and has developed many life-changing medicines that have improved the lives of millions of people around the world. We are proud to be a diverse and inclusive company that values the contributions of our employees and is committed to making a positive impact on the communities we serve.
Job Summary
As an eTMF Specialist, you will play a critical role in managing and executing centralized activities supporting global clinical trials. You will be responsible for uploading and performing rigorous quality reviews of electronic documents residing in the eTMF system, ensuring that they are inspection-ready and compliant with the ALCOA Plus principles. You will also apply filing attributes/metadata as appropriate/required to documents to facilitate classification, management, identification, and accessibility.
Responsibilities
- Manage and execute centralized activities supporting global clinical trials
- Upload and perform rigorous quality reviews of electronic documents residing in the eTMF system
- Apply filing attributes/metadata to documents to facilitate classification, management, identification, and accessibility
- Provide immediate feedback for any quality issue findings
- Interact with regional roles, the study team, and other functional areas within BMS to manage document quality, timeliness, and completeness
- Develops and maintains collaborative working relationships with clinical study teams
- Review of essential regulatory documentation, including submission of final documents to the eTMF
- May provide a level of quality control of start-up activities
- Act as a single point of contact for the study team for centralized activities related to document management
- Ongoing maintenance and tracking of essential records and collection of updated/outstanding documentation
- Proactively resolve issues related to missing or expired documents
- Ongoing communication with study teams regarding centralized document management activities
Requirements
- Minimum of a bachelor’s degree in Life science, Business Administration, or equivalent experience
- 1-2 years of relevant experience in clinical trial documentation management or a clinically related or relevant field
- 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
- Proven experience in managing key internal and external stakeholders effectively
Key Competencies
- Strong organizational, time-management, analytical, and decision-making skills
- 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
Why Work for Us?
At Bristol Myers Squibb, we offer a dynamic and supportive work environment that is dedicated to making a positive impact on the lives of patients. We are committed to fostering a culture of innovation, collaboration, and diversity, and we believe that each of our employees plays an integral role in transforming patients’ lives through science.
Benefits
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
- Recognition and rewards for outstanding performance
- Flexible work arrangements, including hybrid work model and remote work options
