Line Head eTMF Specialists

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

JOB DESCRIPTION

Date Modified: 05 November 2024

Job Title: Line Head eTMF Specialists

Division: Research & Development

Functional Area Description Global Development Operations / Trial Delivery Support / TMF & Transparency

Position Summary /Objective        

• This is a supervisory position overseeing a team of eTMF Specialists responsible for document upload and management in the electronic Trial Master File (eTMF) in support of BMS Clinical Trials across the enterprise.

Position Responsibilities    

• Manages the allocation of workload across a team of eTMF Specialists.
• Oversee the upload and performance of quality reviews of electronic documents residing in the eTMF system to ensure they are inspection-ready and are compliant with the ICH/GCP and ALCOA Plus principles.
• Training and overseeing that the team is filing attributes/metadata as appropriate/required to documents to facilitate classification, management, identification, and accessibility to retrieve files.
• Actively manage and develop direct reports; ensure creation of annual objectives, completion of mid-year and end-of-year evaluations in accordance with company standards and timelines; oversee training on eTMF and other systems, procedures, procedural documents, and Health Authority regulations.
• Prioritizes book of work for eTMF Specialists and assigns resources based on priority of projects.
• Collaborates across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements for maintenance of compliant TMFs and identify efficiency opportunities.
• Maintains continuous knowledge of the regulatory requirements and industry trends related to TMF compliance.
• Communicate as appropriate with relevant stakeholders.
• Leads and participates in continuous improvement initiatives related to clinical trial documentation and TMF compliance.
• Address gaps in TMF compliance as highlighted by Quality metrics and KPIs
• Must be competent in Project Management tools and methodologies.
• Excellent organizational and time management skills
• Strong analytical, problem-solving, and critical thinking skills
• Must be able to interact and communicate effectively at all levels of the organization.
• Undertake remediation where necessary to ensure eTMF documents meet user/requestor requirements.
• Maintain the integrity of the departmental strategy and operating model by ensuring Quality Reviews follow the company’s Standard Operating Procedures (SOPs’), Directives, and industry best practice, and that assigned Quality Reviews are appropriately documented in the department’s SharePoint trackers and other systems of record.

Degree Requirements           

• Minimum of a bachelor’s degree in Life science, Business Administration, or equivalent experience. Advance degree a plus.

Experience Requirements 

• At least 5-7 years of experience in health sciences or related industry
• Supervisory responsibility for eTM, provides training, support, and coaching as required 
• Strong working knowledge of TMF, eTMF and clinical document management systems, preferably Veeva Vault eTMF.
• Strong organizational and technical ability. Ability to create reports and dashboards in eTMF.
• Demonstrated Excel, PowerPoint, and SharePoint skills.  
• Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management.
• Demonstrated ability to create/provide TMF related training and coaching to a broad range of stakeholders.

Key Competency Requirements   

• Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (ICH-E6)
• Experience in directly managing, leading and developing employees, and collaborating with professional colleagues and peers
• Subject Matter Expert knowledge of clinical trial documentation, TMF Reference Model, clinical trial activities and related terminology
• Must have knowledge of Study, Country, and Site level essential documents.
• Strong leadership and people management skills.
• Ability to prioritize work and assess risk to meet the needs of the organization.
• Adaptable and able to modify personal and organizational work style to meet the needs of the business.
• Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review highly motivated and passionate about continuous learning and organizational development.
• Very strong communication and interpersonal skills, verbal and written, is required

Travel Required Occasional

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment:N/A

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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