Senior Clinical Trial Management Leader
2 days ago
Bristol Myers Squibb is a leading global pharmaceutical company dedicated to discovering, developing, and delivering innovative therapies to patients with serious diseases.
Estimated Salary: $120,000 - $180,000 per year
Job DescriptionThis Senior Clinical Trial Management Leader role plays a critical part in our mission by overseeing the execution of clinical trials. As a Line Manager for the Global Trial Acceleration Center, you will be responsible for managing a team of Senior Document Coordinators and Document Coordinators, focusing on document creation, CTA package development, and vendor service support for BMS Clinical Trials across the enterprise.
You will engage closely with clinical trial vendors across multiple service categories, ensuring seamless collaboration and effective communication throughout the clinical trial process.
Key Responsibilities:
- Manage and execute centralized activities in support of global trials with an emphasis on clinical documentation.
- Perform performance management, career development, and coaching of Senior Document Coordinators and Document Coordinators.
- Maintain Department Leadership Team focus on development, accountability, and success of team members.
- Lead or contribute to department process and continuous improvement activities.
- Participate in cross-organizational processes and initiatives.
- Foster partnerships across global and/or multidisciplinary teams using interpersonal and influencing skills.
- Assign work tasks to direct reports and manage their workload.
- Contribute to resource allocation decisions, considering strategic objectives to ensure optimal fit.
- Develop and monitor career development plans with direct reports.
- Engage in performance management, including regular check-ins and year-end evaluations.
- Cultivate individual development needs and coach for success.
- Support compensation decisions.
- Collaborate with fellow Line Managers to enhance department processes.
- Share Lessons Learned related to people management or process improvements.
- Participate in Continuous Improvement efforts within Clinical Operations or the greater Bristol Myers Squibb organization.
- Interact with Regional Country Operation (RCO) teams, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo), the study team, and other functional areas within BMS, providing support to the Study Team during start-up, maintenance, and close-out of clinical studies.
- May perform quality control checks on start-up activities.
- Update and review various study-related clinical systems to determine and report status of clinical trial documents for insourced studies (e.g., CTMS, eTMF, etc.) or corresponding vendor systems.
- Act as single point of contact for centralized activities during study start-up, maintenance, and close-out.
- Communicate regularly with Regional Clinical Operations team (RCO) regarding centralized study activities and country working groups (CWG).
- May create and manage standardized document templates.
- Assist with other duties as assigned to support Clinical Trials.
The ideal candidate will have a strong background in pharmaceutical industry experience, preferably with line management responsibilities. Advanced knowledge of ICH/GCP guidelines and regulatory directives is essential, along with excellent organizational, time-management, analytical, and decision-making skills. Proficiency in MS Office suite, SharePoint, CTMS, and other clinical trial enabling technologies is also required. The ability to effectively manage cross-functional, multi-cultural teams and navigate matrix structures is crucial for success in this role.
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