Bristol-Myers Squibb Company

Clinical Trial Documentation Process Lead

Hopewell, NJ, United States
Jun 07, 2019
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

Provide leadership strategic direction across R&D functions to ensure TMF processes and related documentation are of the highest quality for closed out/archived studies in-house and outsourced

Work closely with the TMF Global Process Lead 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 a global, cross functional work stream aimed at the optimization of the Quality Management System (QMS) for the archival and retrieval of study documentation in the TMF, partnering with business, IT, and HR leadership and manage the delivery of key milestones across internal business, IT, third party vendors, and service providers

Actively engage with leadership from business case development through program delivery, ensure organizational alignment on scope, schedule, quality, benefits and implement and monitor appropriate controls to proactively address barriers to completion

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 the Policy Evaluation Committee or other internal work streams for assessing impact on E2E GXP Quality Management System

Maintain global processes, procedures, and training materials to ensure inspection readiness for completed studies, in compliance with ICH E6(R2) requirements, BMS Global Quality Standards, BMS Quality Management System and ALCOA-CCEA principles

Support development and governance of global processes for TMF archival and document retrieval by close cooperation with relevant functions and site/country 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 Lead, supports BMS audit/inspection readiness activities and consult with all relevant functions within and outside GCO to ensure readiness

Collaborate with the TMF Global Process lead in defining a TMF Community of Practice (COP) across functions involved in clinical trial conduct, 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 archival and retrieval processes

Set the strategic vision for and advise study teams on TMF inspection readiness activities for archived studies. May manage FTEs responsible for activities oversight, as appropriate

Define control framework for archived/completed studies and related monitoring methods, including data collection and analysis, metrics, and associated targets, and reporting mechanisms including both process quality and effectiveness aspects

Maintains 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 archiving operating model as needed.

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 PLs

Maintain high level knowledge of global record retention requirements as well as changes at local level


Minimum of a Bachelor degreein 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


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 at study close out and relative archival practices

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

Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities

High level knowledge of global record retention requirements as well as changes at local level

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