Line Manager, Global Trial Acceleration Center
1 day ago
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Position Summary:
- This role has line managerial accountability over a team of Senior Document Coordinator and Document Coordinator focusing on document, CTA package creation and support of vendor services which support BMS Clinical Trials across the enterprise and engages closely with clinical trial vendors across multiple service categories of clinical trial activities in R&D.
Key Responsibilities:
- The Line Manager, Global Trial Acceleration Center is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation.
- Manages performance and career development of Senior Document Coordinators and Document Coordinators.
- Member of the Department Leadership Team focused on development, accountability, and success of team members
- Leads or contributes to department process and continuous improvement activities.
- Contributes to cross organizational processes and initiatives.
- Leverages interpersonal and influencing skills to foster partnerships across global and/or multidisciplinary teams.
- Manages direct reports work assignments.
- Contributes to resource allocation decisions, considering strategy to ensure best fits for work assignment.
- Partners with direct reports to create and monitor career development plans.
- Manages performance including check-ins and year-end activities.
- Identifies individual development needs and coach for success.
- Contributes to compensation decisions.
- Collaborates with Line Manager colleagues to develop and enhance department processes.
- Shares Lessons Learned relative to people management or process.
- Leads or contributes to Continuous Improvement efforts within the greater Clinical Operations or BMS organization.
- The Line Manager will interact with Regional Country Operation (RCO) team, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitor (CTMo), the study team and other functional areas within BMS and will provide support to the Study Team during start-up, maintenance, and close-out of clinical studies.
- May provide a level of quality control of start-up activity.
- Update and review of various study-related clinical systems to determine and report status of clinical trial documents for insourced studies (i.e., CTMS, eTMF, etc. or corresponding vendor systems)
- Act as single point of contact for centralized activities during study start up, maintenance and closeout activities.
- Ongoing communication with Regional Clinical Operations team (RCO) regarding centralized study activities and country working groups (CWG).
- May be responsible for creation and management of standardized document templates.
- Other duties as assigned to support Clinical Trials.
Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.
Qualifications & Experience:
- Minimum of a BA or BS Degree in Legal, Life science, Business Administration or equivalent. Advanced degree a plus.
- Minimum 5 years of pharmaceutical industry experience or equivalent needed, Demonstrated leadership skills.
- Prior experience in line management (talent identification, development, coaching, performance management) and resource allocation preferred.
- Advanced knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma, Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.
- Excellent Computer skills - MS office suite, Sharepoint, etc. CTMS (Veeva experience preferred, knowledge of portals, databases and other Clinical Trial enabling technologies
- Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.
- Effective management of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
- Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
- Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
- Ability to sustain high levels of performance in a constantly changing environment.
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