Senior Manager, Clinical Trial Management - FSP

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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.

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 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.

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.