Senior Manager, Clinical Trial Management - FSP
Job Summary:
The Sr. Manager, Clinical Trial Management is accountable for the end-to-end clinical trial delivery, providing operational leadership and oversight of cross-functional deliverables and leading a cross functional trial team to build and deliver the trial operational plan. This role is responsible for identifying and mitigating risks to effectively deliver assigned trials on time, within budget, and in a compliant manner.
Key Responsibilities:
• Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL/ CSR/ TLR planning and scope, define protocol deviations and resolution pathways).
• Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
• Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
• Identify risks and ensure mitigations and contingencies are being initiated and followed through
• Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight
• Participate in process improvement activities at a trial and department level as needed
• Mentor & support onboarding of new team members, particularly those in Study Management.
• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
• Support and provide input into internal governance presentations & updates
• Ability to travel approximately 10% but flexibility to go over or below as per business need.
Qualifications:
• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience gained directly with a CRO, Biotech or Pharmaceutical Company leading on Phase 1-4 global clinical trials end to end.
• 3-5 years direct experience leading end to end global clinical trials
• Experience overseeing/leading global trials outsourced to a CRO vendor and ability to manage all aspects of execution of a clinical trial
• Excellent decision-making, analytical and financial management skills are essential to this position
• Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
• Experience in leading without authority and in multifunctional matrixed and global environments
• Experience mentoring/ coaching others
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• Strong project planning/ management, communication (written and verbal) and presentation skills
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
#LI-CF1
#LI-REMOTE
The Sr. Manager, Clinical Trial Management is accountable for the end-to-end clinical trial delivery, providing operational leadership and oversight of cross-functional deliverables and leading a cross functional trial team to build and deliver the trial operational plan. This role is responsible for identifying and mitigating risks to effectively deliver assigned trials on time, within budget, and in a compliant manner.
Key Responsibilities:
• Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL/ CSR/ TLR planning and scope, define protocol deviations and resolution pathways).
• Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
• Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
• Identify risks and ensure mitigations and contingencies are being initiated and followed through
• Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight
• Participate in process improvement activities at a trial and department level as needed
• Mentor & support onboarding of new team members, particularly those in Study Management.
• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
• Support and provide input into internal governance presentations & updates
• Ability to travel approximately 10% but flexibility to go over or below as per business need.
Qualifications:
• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience gained directly with a CRO, Biotech or Pharmaceutical Company leading on Phase 1-4 global clinical trials end to end.
• 3-5 years direct experience leading end to end global clinical trials
• Experience overseeing/leading global trials outsourced to a CRO vendor and ability to manage all aspects of execution of a clinical trial
• Excellent decision-making, analytical and financial management skills are essential to this position
• Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
• Experience in leading without authority and in multifunctional matrixed and global environments
• Experience mentoring/ coaching others
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• Strong project planning/ management, communication (written and verbal) and presentation skills
• Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
#LI-CF1
#LI-REMOTE