TMF Global End to End Process Lead

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Position 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 sub-processes. 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 high-quality TMF end to end processes for in-house and outsourced studies.
• Provide management oversight to TMF study leads, Archival Leads and Local Process Leads responsible for maintaining, monitoring and/or executing the end-to-end 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 end-to-end 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 end-to-end 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 ALCOA-CCEA 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 bachelor's degree in Science, Pharmacy, or related field
• Master's 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 track-record of several years managing cross-functional 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 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 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.
On-site Protocol
BMS has an 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.
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