Orchard Therapeutics Limited is a global biotechnology company based in the UK and the US that is dedicated to bringing transformative gene therapies to children with severe and life-threatening orphan diseases. The company has been founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions.
Reporting to the Head of Clinical Operations and Project Management, the Clinical Project Manager will be accountable for managing the clinical operation activities for 2 to 3 clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP.
About us: Orchard Therapeutics Limited
Orchard’s ambition is to be recognized a global leader in the development and commercialization of transformative gene therapy medicines for children with severe and life-threatening orphan diseases.
Orchard’s Leadership team and collaborators have more than a decade of experience in the development, manufacturing and commercialization of advanced therapies for rare diseases. We work in partnership with the world’s most prestigious research centres to harness the life-giving potential of gene therapy.
Our mission is to provide the ideal environment and expertise to translate promising pre-clinical and early clinical results into commercially approved medicines available to patients around the world.
Members of our research consortium include University College London and Great Ormond Street Hospital (UK), London; University of Manchester (UK); University of California Los Angeles, CA (US); Boston Children’s Hospital, MA (US); and Genethon, Evry (France).
Our programmes leverage the potential of pioneering gene therapy technologies to restore normal gene function in patients with primary immune deficiencies and metabolic diseases. Indications currently under investigation include primary immune deficiencies, hematologic and metabolic disorders.
- Lead, manage and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCP
- Oversees the quality of the clinical operations for the studies he/she is in charge of?
- Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
o Coordinates medical writing and all the activities necessary for delivering of documentation: publishing, QC, etc
o Manages data management and statisticians ensuring data base maintenance, database lock, etc
o Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies)
- Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
- Ensuring implementation and conduct of study(ies) in accordance with ICH-GCP guidelines
o Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.?
o Manages CRFs creation, implementation, ensuring data management is properly for the study activities
o Ensures accurate maintenance and archiving of study records
o Oversees (e)TMF
- Management of study budget and timelines
- Management of vendors to the required standards
- 3-5 years of knowledge of clinical project management
- Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
- Understanding of regulatory environment, GCP/ICH
- Experience working in an academic environment is a plus, as well as experience in orphan disease field
- Excellent organisational and communication skills;
- ‘Can-do’ attitude and willingness to be flexible