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Senior Clinical Trial Manager - Rare Diseases Gene/Cell Therapy

Location Houston, United States
Posted 12-January-2019
Description

Clinical Trial Manager - Rare Diseases and Gene/Cell Therapy

Home Based anywhere in US

- As a CTM you would be expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients
- Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects
- Contribute to the development and maintenance of cross functional project management plans
- Responsible for risk mitigation strategies, associated action plan and issue resolution
- Responsible for managing the Clinical Operations project team, including ensuring all necessary project training is provided to assigned staff
- Provide direction and support to the Clinical Operations study team
- Collaborate with Business Development (BD) to ensure timely completion of change orders
- Track Clinical Operations project deliverables using appropriate tools
Role Requirements

- Must have experience in Rare Diseases and/or Gene/Cell Therapy trials.
- Must have previous experience in a Clinical Trial Manager role.
- University/Bachelors Degree in medicine, science or equivalent degree/experience.
- A satisfactory progression of monitoring experience with previous experience in leadership and/or management activities
- Previous working experience within the clinical trial management field.
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
- Some knowledge of project management processes and tools.
- Fluent in written and spoken English.
- Computer literate.
- Due to the nature of this position it may be required for the employee to travel approx 25%. Therefore, dependent on the employees location, the employee may be required to possess a valid Drivers license

 
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