Accountable for the end-to-end clinical trial delivery
Provide operational leadership and oversight of cross-functional deliverables
Lead a cross functional trial team to build and deliver the trial operational plan
Identify and mitigate risks to effectively deliver assigned trials on time, within budget, and in a compliant manner
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
Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance
Proactively ensure that trial deliverables and milestones are met
Ensure trial is operationalized in compliance with global health authority regulations and guidelines
Mentor & support onboarding of new team members
Provide variance analysis of budget to actual and notify finance of projected cost over/under expenditure
Requirements
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
Excellent leadership skills, proven ability to foster team productivity and cohesiveness
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
Strong reasoning and problem-solving ability
Strong project planning/management skills
Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project