Clinical Trial Administrator
- Employer
- Orchard Therapeutics
- Location
- London, United Kingdom
- Start date
- Sep 15, 2021
View more
- Discipline
- Clinical, Clinical Trials
- Required Education
- Bachelors Degree
- Position Type
- Full time
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Clinical Trial Administrator
Location: London
Reporting to: Manager / Senior Manager of Clinical Operations
Reporting to the Manager / Senior Manager of Clinical Operations, the Clinical Trial Administrator (CTA) will be responsible for providing project administrative and tracking support to the Clinical Study Managers for their assigned clinical studies. The CTA will be responsible for supporting individual studies, as well as participating in process improvement initiatives for the department.
This person will be key in supporting with the clinical studies day to day activities, ensuring on time delivery of main clinical milestones in accordance with ICH GCP as well as supporting general department activities and initiatives.
Responsibilities
Requirements
Experience ideally required
Education & skills
Location: London
Reporting to: Manager / Senior Manager of Clinical Operations
Reporting to the Manager / Senior Manager of Clinical Operations, the Clinical Trial Administrator (CTA) will be responsible for providing project administrative and tracking support to the Clinical Study Managers for their assigned clinical studies. The CTA will be responsible for supporting individual studies, as well as participating in process improvement initiatives for the department.
This person will be key in supporting with the clinical studies day to day activities, ensuring on time delivery of main clinical milestones in accordance with ICH GCP as well as supporting general department activities and initiatives.
Responsibilities
- Provide full support to the Clinical Study Managers and members of the Clinical Operations team as required
- Maintains Sponsor Oversight Files for assigned studies and facilitate flow of documentation between sponsor and CRO-held TMF
- Review & oversight of TMFs for the programs
- Maintains study trackers to support Clinical Study Managers with oversight of study timelines, key milestones and progress reporting
- Prepare and issue meeting minutes where required, including action items, under the direction of Clinical Study Managers
- Collaborates with Finance on PO and invoice reconciliation to support Clinical Study Manager with oversight of study budget and financial reporting
- Collaborates with other internal and external partners to faciltate communication, information and documentation flow as required (e.g. Regulatory Affairs, Clinical Science, central laboratory)
Requirements
Experience ideally required
- Experience & knowledge of clinical trials, particularly co-ordination/administration
- Previous CTA experience.
- Experience in working with CROs and vendors
- BsC in life sciences or RN
- Excellent organisational, interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
- Able to work effectively in a fast-paced environment using different systems
- Ability to prioritise and manage multiple tasks.
- Confidently and accurately uses MSOffice and project management tools
- 'Can-do' attitude and willingness to be flexible
Education & skills
- BsC in life sciences or RN
- Excellent organisational, interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
- Able to work effectively in a fast-paced environment using different systems
- Ability to prioritise and manage multiple tasks.
- Confidently and accurately uses MSOffice and project management tools
- 'Can-do' attitude and willingness to be flexible
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