Senior Manager, Clinical Trial Management - FSP
Behavioral Health Market Context
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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
- •8 more items(s)
Responsibilities
- •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
- •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
- •13 more items(s)
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