Senior Clinical Trial Manager - US or Canada - FSP

​​​The Senior Clinical Trials Manager (Sr. CTM) will be a member of the client’s Clinical Operations team.​​

Key Accountabilities:

Oversight of activities

• Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team.  

• Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials  

• Provide direction and leadership in CRO and vendor selection and management.  

• Knowledge of regulatory start up process and planning in support of study start up  

• Managing and maintaining high performing clinical teams  

• Coordination of global clinical trials  

• Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.  

• Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.  

• Be responsible for and manage clinical research activity of Clinical Operations team  

• Estimate, track and critically analyze vendor financial spend on study   

• Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs  

• Provide guidance, direction, and management to site monitoring activity  

• Coordinate patient enrollment activities and mitigation planning  

• Coordinate study supplies with regulatory and clinical supplies functions  

• Negotiate contracts with vendors of clinical trial services  

• Review Informed Consent Forms, CRFs, and study related materials  

• Plan and participate in investigator meetings  

• Assist and support data query process  

• Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines  

• Ensures trial master file is current and maintained 

Collaborative relationships 

• Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials. Collaborate in the development of programming specifications. 

Skills: 

• Excellent oral and written communication skills and strong organizational abilities  

• Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)  

• Demonstrated ability to work independently and in a team environment  

• Ability to prioritize and manage multiple tasks simultaneously.  

• Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.  

Knowledge and Experience:  

• Proven experience of clinical trial management  

• Proven management of people in a matrixed environment  

• Experience in CNS and / or oncology is preferred  

• Management of global clinical trials  

• Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations  

• Travel required. Must be willing to travel 15-25%, including international travel.  

• Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)   

Education: 

•  BA/BS, nursing degree, or advanced degree.  Degree in the life sciences preferred  

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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.