Regional Clinical Study Senior Manager

Position Summary

Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget
Acts as regional lead for multiple studies across an indication or across a program as required
Leads the regional clinical operations team (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned study
Ensures alignment of regional deliverables with overall study goals
Contributes to the development of regional tools and leads the development of work instructions and SOPs as required

Essential Functions Of The Job

• Regional Leadership
  Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study
  Leads external vendors involved in study delivery on a regional level
  Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required
  Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings
  Leads regional operations meetings with all regional study team members
  Displays therapeutic area knowledge and expertise
• Timelines, Planning and Execution
  Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
  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, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders
  Provides regional input on global study plans as required
  Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs
  Accounts for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs
  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
  Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC’d on a regular basis as per the study TMF QC plan
  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
  As required, 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
  Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations
  Ensures 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
  Manages the trial data collection process for the region, drives data entry and query resolution
  As required, 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
  Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations
  Ensures 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
  Manages the trial data collection process for the region, drives data entry and query resolution
  As required, 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
  Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations
  Ensures 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
• 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
  Monitors regional resource utilization over study life cyle and liaises with functional managers as needed
• Supervisory Responsibilities
  Provides performance feedback on team members as required
  Mentors junior team members and might take on line management responsibilities as required

Computer Skills

MS Office, Project Planning Applications

Other Qualifications

• 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
  Proven experience in clinical research including relevant experience as team lead in clinical functions
  Experience as CRA is preferred
• Travel
  Travel might be required as per business need

Education

Required: Bachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred exceptions might be made for candidates with relevant clinical operations experience

Global Competencies

• Fosters Teamwork
• Solicits Honest and Actionable Feedback
• Self-Awareness
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$136,400.00 - $181,400.00 annually