CT Model Documents Lead
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.
This role will report to the Director, Global Clinical Trial Documentation, Submissions and Disclosure, who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI) leadership team under Global Clinical Operations (GCO). 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, 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 are shared internally across functions as appropriate and externally with our partners, investigators, IRB/ERBs and Health Authorities.
- Develop and maintain a thorough understanding of, and document, ICH/regulatory requirements and industry standards governing Clinical Trial Model Documents.
- Develop, implement, and maintain 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 templates for all Clinical Trials in all countries.
- This role will lead the transition to, and implementation of the TransCelerate Protocol Model Document and Common CSR Template.
- Collaborate with colleagues in Drug Development, Clinical, Medical Affairs, Operations Leads and Regional Operations, Protocol Managers, Data Management, Clinical Trial Engagement team, 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 document.
- 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.
- Partner 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, 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.).
- A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 8 years in the pharmaceutical industry and 5 years of experience in clinical trial operations and/or Good Clinical Practice is required.
- Experience in Lean Sigma is a plus with a mindset for Simplification. Knowledge of CARA, VeeVa, ECLIPSE, SharePoint and other systems is desirable.
- 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.
- Experience in matrix management and training is desirable with the ability to engage and inspire others. Good 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). Good 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.