Clinical Operations Leader / Clinical Trial Manager - FSP

Job 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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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.