Global Trial Manager
vor 1 Tag
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
**Position Title**
Global Trial Manager
**Position Summary**
GTM leads successful and timely operational execution of global insourced or outsourced, Non-Registrational Data Generating or Registrational Data Generating interventional clinical trials from concept to final clinical study report.
GTM acts as the primary operational contact for the study and leads the cross-functional global team for execution of the study.
GTM provides quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
GTM focuses on project management concepts to support management of issues, risks, timelines, and budget and ensures quality compliance with ICH/GCP, Regulatory Authorities regulations/guidelines, and applicable SOPs/WPs.
**Position Responsibilities**
**_ Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following: _**
**Project Management**
- Drives study execution utilizing available performance metrics and quality indicators (e.g. CTMS, eTMF reports, RBM reports), and study milestones and drivers.
- Develops, manages, and maintains study deliverables (i.e. timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions.
**Study Planning and Conduct - Insourced Studies**
- Provides input to data, protocol deviation review, and patient tracker.
- Provides strategic input into Study Team - e.g., on study documents.
**Study Planning and Conduct - Outsourced Studies**
- Reviews/approves functional plans (e.g. SAE management plan, PSV waivers, BMS confidentiality agreement for sites with master agreements with BMS).
- Provides information to the CRO and reviews CRO deliverables.
**Relationship Management**
- Proactively develops/maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.
**Leadership Competencies**
- Creates realistic plans that clearly define goals, milestones, responsibilities, and results.
- Maintains focus on strategic objectives while accomplishing operational goals.
**Degree Requirements**
BA/BS or equivalent degree in relevant discipline
**Experience Requirements**
- Significant, demonstrated project management experience of which should have been in the pharmaceutical or healthcare industry.
- Experience in leading global clinical trials and multi-functional teams.
- Demonstrated project management and organizational skills with strong presentation and communication abilities.
- Experience with electronic quality, compliance and CTMS systems. Experience in managing CROs is a plus.
- Risk management experience preferred.
**Key Competency Requirements**
**Technical Competencies**
- Clinical trial project management skills
- Financial budgeting and forecasting skills are a plus.
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.
- Proven success in using oral/written communication skills to influence, inform, or guide others.
- Proficiency in study tools including electronic system skills - e.g. CTMS/eTMF.
**Management Competencies**
- Understands interdependencies, links possible solutions, and escalates issues with proposed solutions to appropriate people.
- Reacts with a sense of urgency and responds appropriately.
- Critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines.
- Adaptable and flexible—willing/able to adjust to multiple demands and shifting priorities and demonstrates ability to meet day-to-day challenges with confidence and professionalism.
- Has the command of the projects, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside of BMS (as appropriate).
- Ability to effectively lead a cross-functional team in a matrix environment.
- Fosters a continuous learning mindset.
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 with the resources to pursue their goals, both at work and in their personal lives.
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