Bristol-Myers Squibb Company

Clinical Study Protocol and Report Documentation Process Lead

Location
Princeton, NJ, United States
Posted
Aug 13, 2019
Ref
R1517121
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

The purpose of this role is to provide global leadership for key Quality processes, ensuring adherence to procedural document processes, proper documentation of processes, driving process optimization and improvement, ensuring that resources are identified and aligned at the cross-functional team level to drive improvement activities, and leading optimization activities to align with Good Clinical Practices (GCP). This will include serving as the key point of contact for the assigned global process and local sub-processes. The Clinical Study Protocol and Report Documentation PL will ensure role definition and clarity on key accountabilities for process steps through an enterprise lens. The Clinical Study Protocol and Report Documentation PL will establish, track, and trend process metrics to achieve Quality Outcomes and will lead the Community of Practice with Local Process Owners (LPOs), other Process Leads (PLs), and Subject Matter Experts (SMEs).

The Clinical Study Protocol and Report Documentation PL reports into the Head of Global Scientific Regulatory Documentation, who is also the End to End Protocol to Clinical Study Report Process Owner.

Responsibilities

Provide leadership and strategic direction across R&D functions to ensure documentation related to clinical protocols and clinical study reports are of the highest quality for BMS-sponsored studies.

Provide guidance to clinical teams

Work closely with the GSRD, GMD, and GCO Leadership to ensure the end to end process protocol and clinical study report development, review, approval, and finalization in PRISM 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 development and approval of study protocols and protocol revisions and clinical study reports in PRISM, 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) and ICH E3 requirements, BMS Global Quality Standards, BMS Quality Management System and ALCOA-CCEA principles

Maintain awareness of new regulatory guidance impacting protocol and clinical study report development requirements, and provide guidance and training to GSRD members on maintaining compliance

Define control framework for protocol revisions and CSR content alignment, and update/adapt as needed to reflect evolving regulatory environment

In collaboration with the GSRD Functional Managers, support BMS audit/inspection readiness activities and consult with all relevant functions within and outside GSRD to ensure readiness

Collaborate with the other functional area Process Leads in defining a Community of Practice (COP) across functions involved in clinical study conduct and reporting, 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 Clinical Study 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 inspection readiness activities. May manage FTEs responsible for activities oversight, as appropriate

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 Clinical Study Protocol and Clinical Study Report 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 clinical protocol and clinical study report requirements as well as changes at local level

Education

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

Experience/Knowledge

A minimum of 10 years of clinical operations, regulatory, pharmacovigilance, or other relevant biopharmaceutical industry experience, including at least 5 years in regulatory documentation 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 documents and related practices

Thorough knowledge of the main platforms used across the industry to maintain Clinical Study Documentation, electronic TMF (eTMF) and related processes

High level knowledge of protocol and clinical study report requirements as well as changes at local level

Experience with GCP related audits/inspections

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

Skills/Competencies

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

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 the resources to pursue their goals, both at work and in their personal lives.