TMF Global End to End Process Lead
TMF Global End to End Process Lead
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving teams. 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: Summary
The TMF Global End to End Process Lead provides global leadership for the TMF key processes ensuring completeness legibility accuracy and retrievability of essential documents throughout the study life cycle.
This role drives process optimization aligns resources to support critical activities at study and/portfolio level and ensures compliance with TMF requirements.
This role also serves as the key point of contact for global and local subprocesses. The TMF end to end Global Process Lead will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens. This role will establish track and trend process metrics to achieve a high quality complete and contemporaneous TMF.
Duties/Responsibilities
Lead and provide strategic direction across R&D functions to ensure highquality TMF end to end processes for inhouse and outsourced studies.
Provide management oversight to TMF study leads Archival Leads and Local Process Leads responsible for maintaining monitoring and/or executing the endtoend process.
In collaboration with business stakeholders and IT Business Partners define TMF migration strategies from CROs third parties and newly acquired companies.
Work closely with the eTMF Operations Lead the eTMF System Business Owner and IT Business Partners to ensure the endtoend process for document management and archival in the TMF is of high quality and in line with industry standards
Lead global cross functional efforts aimed at the optimization of the Quality Management System (QMS) for the endtoend TMF process including archival and retrieval of study documentation in the TMF partnering with business IT and manage the delivery of key milestones across internal business IT third party vendors and service providers.
Maintain global processes procedures and training materials to ensure inspection readiness for completed studies in compliance with ICH E6 requirements BMS Global Quality Standards BMS Quality Management System and ALCOACCEA principles
Support the development and governance of global processes for TMF by close cooperation with relevant functions and Local Process Leads.
Identify the named archivist(s) for paper and electronic records as required by regulations and provide training support and coaching as required.
In collaboration with the Global TMF Process Owner support BMS audit/inspection readiness activities and consult with all relevant functions within and outside Global Development Operations (GDO) to ensure readiness.
Define and Lead a TMF Community of Practice (COP) across clinical trial functions including roles operating principles communication strategies and levels of training and access. Provide leadership coaching and training for COP members including both the technical processes and the behaviors necessary to optimize process execution.
Liaise with Global Quality Continuous Improvement and other functional leaders to ensure the TMF COP is supported and empowered to define and implement improvement to the TMF processes.
Set the strategic vision for and advise study teams on TMF inspection readiness activities.
Define control framework for inhouse and outsourced studies and related monitoring methods including data collection and analysis metrics and associated targets and reporting mechanisms including both process quality and effectiveness aspects.
Utilize metrics and trend analysis to identify and prioritize process improvements. Provide data and input to drive other continuous improvement efforts across the enterprise as applicable which may include priority and timing collaboration with other Process Leads.
Maintain global expertise through training and participation at conferences and in industry forums. Maintain awareness of evolving regulations standards technology and best practices and channel appropriate intelligence into our business model. Evolve the TMF operating model as needed.
Participate/lead benchmarking initiatives with peers externally to stay abreast of new ways of working and evolving technologies. Bring ideas and external Regulatory intelligence to internal stakeholders for assessing impact on TMF processes.
Maintain high level knowledge of global record retention requirements as well as changes at local level.
Reporting Relationship
- Reports into the Head of TMF and Transparency (TDS) who is also the TMF Global Process Owner (GPO) and is part of the TDS Leadership Team
Education/Degrees:
Minimum of a bachelors degree in Science Pharmacy or related field
Masters Degree and/or PMP certification with 10 plus years experience in pharmaceutical industry in concentrated disciplines of R&D Clinical Operations and/or Clinical Quality preferred
Experience:
A minimum of 10 years of clinical operations regulatory pharmacovigilance or other relevant biopharmaceutical industry experience including at least 5 years in TMF management and inspection readiness or related position
Mastery of relevant Quality compliance processes and regulations e.g. Good Clinical Practices (GCP) and Good Documentation practices
Mastery of processes related to the maintenance of an inspection ready TMF.
Thorough knowledge of the main platforms used across the industry to maintain an electronic TMF (eTMF) and related processes
High level knowledge of global record retention requirements as well as changes at local level
Experience with GCP related audits/inspections is required
Strong program and project management experience with proven trackrecord of several years managing crossfunctional programs and ability to manage multiple simultaneous projects.
Skills/Abilities:
Demonstrated influential leadership expertise and experience with senior level interactions and influence across internal and external stakeholders
Demonstrated Enterprise mindset to be able to think and act across functions and divisions
Demonstrated ability to work in a matrixed organization with a range of technically culturally and geographically diverse teams and to influence areas not under direct control to achieve objectives
Demonstrated people management experience
Excellent teamwork interpersonal and communication skills with the ability to communicate and collaborate with employees and management at all levels and through various formats
Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities
Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed quality and risk
Demonstrated change agility in anticipating and leading others through change and ambiguity
Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance.
Travel:
Occasional
If you come across a role that intrigues you but doesnt 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 Lifechanging 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 a supportive culture promoting global participation 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100% of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Exec
Employment Type
Full-Time
