Job Description
Job Summary:
Join our team as a Senior Manager of Clinical Trial Operations, where you will play a pivotal role in ensuring the seamless delivery of clinical trials. You will lead a cross-functional team and drive the operational plan for each trial while mitigating risks and guaranteeing compliance. Your expertise will guide the organization toward successful outcomes within budget and on time.
Key Responsibilities:
• Lead a cross-functional trial team to execute the operational plan and oversee end-to-end trial execution effectively.
• Ensure accountability for trial delivery, managing budget, timelines, quality, and key milestones.
• Oversee vendor and CRO relationships, ensuring effective setup, work statements, budget management, and performance metrics.
• Proactively manage trial deliverables and milestones to align with corporate and study-level objectives.
• Identify potential risks and initiate appropriate mitigations and contingency plans.
• Ensure all trials comply with global health authority regulations and internal operating procedures.
• Participate in Health Authority Inspections and internal quality audits, ensuring the trial team is prepared.
• Contribute to continuous process improvement initiatives at both trial and department levels.
• Mentor and onboard new team members, particularly in Study Management roles.
• Engage with internal stakeholders across various functions, fostering collaboration and communication.
• Provide budget variance analysis and timely notifications to finance regarding potential cost adjustments.
• Support governance presentations and provide updates as needed.
• Travel may be required approximately 10%, with flexibility depending on business needs.
Qualifications:
• BS/BA degree is required.
• 7+ years of clinical research experience in a CRO, Biotech, or Pharmaceutical company, managing Phase 1-4 global clinical trials.
• 3-5 years of direct experience leading global clinical trials end-to-end.
• Experience overseeing global trials outsourced to CRO vendors and managing all execution aspects.
• Excellent decision-making, analytical, and financial management skills.
• Strong leadership abilities, fostering team productivity, and capable of working with minimal supervision.
• Proven experience in leading within a multifunctional and global matrix environment.
• Experience in mentoring and coaching team members.
• Exceptional organizational, reasoning, and problem-solving skills, able to handle multiple priorities.
• Strong project planning, communication (both written and verbal), and presentation skills.
• Proficient in MS Office Suite (Excel, Word, and PowerPoint) and MS Project.
#LI-CF1
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, ****** orientation, gender identity, national origin, disability, or protected veteran status.
