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Job description
Job Summary:
The Clinical Trial Manager 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:
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
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
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 aspects of global clinical trials
Experience working with CROs
Education:
Bachelor's degree is required
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, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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Worksite address
helena, MT, 59604, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.