ICON Clinical Research Senior Clinical Trial Manager - Rare Diseases, Gene & Cell Therapy in Marlborough, Massachusetts

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/Bachelor’s 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 employee’s location, the employee may be required to possess a valid Driver’s license