Clinical Trial Model Documents Lead

Profile

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.

Position Summary / Objective

This role will report to the Clinical Trial Model Documents and Informed Consent Process Lead who is a member of the Global Clinical Trial Documents, Submissions and Disclosure leadership team. This role is responsible for the execution of the governance model for global BMS Clinical Model Documents. The Model documents in Clinical Trials are a critical component to maintain consistency of language and compliance to Good Clinical Practice (GCP), ICH regulations, regulatory requirements and industry standards. Model Documents support the creation of Study Protocols, Informed Consent, Clinical Study Reports (CSR), Investigator Brochure, and others. They are maintained in a central repository, governed through a robust change control mechanism, and used to create study documents that can be shared internally across functions as appropriate and externally with our partners, investigators, IRB/ERBs and Health Authorities.

Position Responsibilities

Develop and maintain a thorough understanding of evolving ICH/regulatory requirements and industry standards governing Clinical Trial Model Documents.

Develop, implement, continuously improve and maintain a Model Documents centralized process for all Clinical Operations worldwide. This will require collaborating with all functions involved with content development, content revisions and approval, distribution, change control, translation and repository of all model documents for all clinical trials in all countries. In addition, this role will collaborate with TransCelerate to continue implementation of the Common Protocol Template and other templates as applicable.

Collaborate with colleagues across the Drug Development organizations including, Clinical, Medical, Operations, Data Management, Information Technology, Safety, Regulatory, Translational Medicine, Legal, etc. to ensure appropriate templates for Clinical Trial Model Documents are developed and maintained at the corporate, program, asset, and study levels, throughout the life cycle of the documents.

Provide subject matter expertise and oversight on the process to maintain Model Documents in support of clinical operations, including during audits and inspections.

Collaborate with the Clinical Trial Planning & Alliance Management team to develop appropriate process and communications with Clinical Research Organizations and other external partners to ensure compliance with applicable requirements for the Model Documents.

Collaborate with the Training, Process and Continuous Improvement team to ensure appropriate training of research personnel on use and maintenance of Clinical Trial Model Documents.

Help identify emerging and significant risks affecting the implementation of Model Documents and appropriately notify/escalate.

Work with management and Global Quality to foster a cross-functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times and Growth Mindset.

Keep abreast of the changing regulatory landscape and externally engages as appropriate with industry consortia and professional associations (TransCelerate, PhRMA, EFPIA, etc.).

Degree Requirements

A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred.

Experience Requirements

At least 8 years of experience in the pharmaceutical industry in clinical development, clinical trial operations, medical writing and other disciplines part of drug development.

Good knowledge of Good Clinical Practice is required.

Key Competency Requirements

Extensive knowledge of clinical trial processes and relative documentation, including but not limited to:

Development of Study Protocol, Clinical Study Reports, Informed Consent and other essential documents

Trial Master File, Documentation, and Clinical Trial Master File systems

Working in collaborative virtual environments

Microsoft office suite, including SharePoint

Good understanding of the drug development process and clinical operations.

Experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions (CAPA) process.

Experience in matrix management and training is desirable with the ability to engage and inspire others.

Previous experience with the TransCelerate model document is a plus

Experience in Lean Sigma is a plus with a mindset for continuous improvement and simplification.

Excellent communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities).

Excellent presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner.

Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.

The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.

Travel Required

On occasion

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com