Clinical Trial Associate

Location:         Boston

Reporting to:   Senior Director, Clinical Operations              

Job Summary

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London and its U.S. headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

Reporting to the Director of Clinical Operations, the Clinical Trial Associate (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 able to operate independently on certain CTA related tasks and exercise good judgement and decision making on what to bring to the study manager’s attention. The CRA will have the ability to take on increasing level of study manager responaibilities with guidance from the study manager. The CTA will also be responsible for supporting  individual studies, as well as participating in process improvement initiatives for the department.

This person will be key in supporting the clinical study day to day activities, to ensure on time delivery of main clinical milestones in accordance with ICH GCP as well as supporting general department activities and initiatives.

Key Responsibilities

·         Provide full support to the Clinical Study Managers and members of the Clinical Operations team as required

·         Maintain Sponsor Oversight Files for assigned studies and facilitate flow of documentation between sponsor and CRO-held TMF

·         Review & oversight of TMFs for the programs

·         Maintain 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

·         Collaborate with Finance on PO and invoice reconciliation to support Clinical Study Manager with oversight of study budget and financial reporting

·         Collaborate with other internal and external partners to faciltate communication, information and documentation flow as required (e.g. Regulatory Affairs, Clinical Science, central laboratory)

Experience ideally required

·         Experience & knowledge of supporting clinical trials, particularly co-ordination/administration

·         2-years CTA experience

·         Experience in working with CROs and vendors

Education / Key Competencies

·         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

·         Excellent decision making capabilities