Regional Clinical Study Associate Manager

Essential Functions Of The Job

• Regional Leadership
  • Manages the regional clinical operations team effectively
  • Ensures effective decision making
  • Acts as point of escalation for resolution of issues within the region for the assigned study
  • Drives specific aspects of regional study delivery in collaboration with the Regional Clinical Study (Sr) Manager
  • Learns external vendors involved in study delivery on a regional level
  • Collaborates with key stakeholders in the region and provides regular updates on study progress
  • Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings as applicable
• Timelines, Planning and Execution
  • Manages planning and management of the assigned clinical study(ies) or specific activities from feasibility through closeout activities for region
  • Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these
  • Ensures that the clinical study is operationally feasible in the region, manages trial feasibility, country allocation and site selection process for assigned region
  • Provides regional input on global study plans as required
  • Ensures the timely availability of local adaptations of global study documents such as informed consent forms
  • Ensures the timely submission of study to regulatory authorities and ECs/IRBs
  • Ensures regional and country information in study systems and tools is entered and up to date
  • Collaborates closely with CRAs in the region to ensure proper study execution at the sites
  • Reviews and signs-off monitoring reports
  • Provides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region
  • Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in region
  • Manages the trial data collection process for the region, drives data entry and query resolution
  • Supports planning and execution of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing Quality
  • Handles escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads
  • Marks study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations
  • Maintains inspection readiness for study in region at any point in time throughout the study life cycle
  • Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ensures solutions are implemented
  • Prepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriate
  • Collaborates with CST members and colleagues to ensure cross-team, site learnings, and best practices are shared
  • Leads improvements and partners with CST members to enhance the efficiency and the quality of the work performed on assigned studies
• Budget and Resources
  • Works with the sourcing team to select and manage regional study vendors
  • Manages regional study budgets
  • Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities
  • Identifies and manages regional team resource needs and establishes contingency plans for key resources
  • Maintains regional resource utilization over study life cycle and liaises with functional managers as needed

Qualifications

• Bachelor’s Degree in a scientific or healthcare discipline required, higher degree preferred

Skills

• Strong leadership and management skills
• Excellent communication and collaboration abilities
• Proficient in clinical research protocols and standards
• Ability to manage multiple projects simultaneously
• Strong problem-solving and decision-making skills
• Knowledge of regulatory requirements and GCP guidelines
• Experience with clinical study documentation and data management

Benefits

BeOne offers a comprehensive benefits package that includes:

• Medical, Dental, Vision insurance
• 401(k)
• Flexible Spending Accounts (FSAs) and Health Savings Accounts (HSAs)
• Life insurance
• Paid time off
• Wellness programs

Pay

$96,300.00 - $131,300.00 annually

Schedule

Full-time position