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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Clinical Operations Leader / Clinical Trial Manager - FSP
Job ID R0000036464Job Summary:
The Clinical Operations Leader is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery.
Key Accountabilities:
Oversight of Project Cycle
• Manage integration of project team activities
• Manage strategic study operations including but not limited to study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, budget and financial information, performance metrics, and data flow
• Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specific studies
• Provide input into global subject/patient recruitment plans
• Manage aspects of CRO/vendor identification and the day-to-day operational management activities of CROs and other vendors including set up, statement of work creation, and budget oversight
• Create and update critical trial-specific documents
• Support development of compound and protocol level training materials
• Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
• Provide support for inspection readiness activities including risk identification and mitigation plans at the trial level
• Participate in process improvement activities at a trial and department level as needed
Collaborative Relationships
• Manage relationships between study sites and vendors
• Interface with internal key stakeholders
• Support onboarding of new team members
• Attend stakeholder meetings and provide input and updates on operational activities and progress
Compliance with Parexel Standards
• Complies with required training curriculum
• Completes timesheets accurately and timely as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
• Excellent decision-making, analytical, and financial management skills
• 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 and coaching others
• Exceptional organizational skills and ability to deal with competing priorities
• Strong reasoning and problem-solving abilities
• Strong project planning/management, communications (written and verbal) and presentation skills
• Experience with protocol, informed consent form (ICF), case report form (CRF), and clinical study report (CSR) development and review
• Proficient in MS Office Suite (Excel, Word, and PowerPoint)
• Ability to travel approximately 10%
Knowledge and Experience:
• Minimum 5+ years of clinical research experience gained with a CRO, biotech or pharmaceutical company working on phase I-IV global clinical trials
• 2-3 years leading global clinical trials start up through close out
• Experience working with CROs
• Experience with metabolic, diabetes, obesity or hypertension trials is preferred
Education:
• Bachelor's degree is required
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