Study Manager, Clinical Operations
Location: London
Reporting to: SeniorDirector, Clinical Operations
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.
Job Summary
The Clinical Operations Clinical Study Manager will be accountable for managing the clinical operations activities for approximately 2 to 3 clinical trials depending on the complexity of the trial and lifecycle of the trial as it pertains to resource needs. This person will be key in driving strategic clinical trial operational planning, clinical studies day to day activities including budget management, ensuring on time delivery of main clinical milestones, and most important ensuring patient safety and data integrity while following internal SOPs and ICH/GCP requirements.
Key Responsibilities
· Lead and manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD/CTR, and ICH GCP) and Orchard SOPs.
· Collaborate with cross functional study team(s), including Orchard functions, CRO partners and other vendors to ensure study goals are met, on time and within budget. Includes leading and organizing cross functional clinical team meetings.
· Ensure appropriate Clinical Operations input for studies prior to decision making to ensure proper upfront planning.
· Contribute to protocol development, including Clinical Operations feasibility assessments.
· Manage the evaluation and selection of required vendors, including contract and budget negotiation, task orders, change orders, invoice approval and financial reconciliation process, with oversight of Associate Director/Director.
· Responsible for day-to-day management of vendors working on assigned study/studies, including setting expectations, training, oversight process including attending regular meetings and reviewing metric reports, managing timelines and deliverables, and issue management.
· Provide Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning, organization of investigator and vendor meetings, development of informed consents forms and assent forms, planning and management of Trial Master File, development of study plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, contributing to the Clinical Study Report.
· Escalate medical issues to appropriate Orchard medical personnel.
· Management of study budget and provision of regular budget updates to Finance. This includes forecasting for study budget for years ahead, monthly accruals and quarterly budget reviews as part of the Latest Estimate (LE) process, to ensure the study is conducted within budget and any discrepancies or changes are communicated to the Associate Director/Director who provides oversight, as well as to finance.
· In collaboration with the Clinical Team (Orchard functions, CRO Partners, and vendors), identify risks to study and suggest risk mitigation plans, with oversight of Associate Director/Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
· Ensure study documentation is maintained according to applicable regulations, industry standards, and SOPs.
· Provide mentorship/management if applicable of more junior members of clinical operations.
· Participate and lead internal process improvement efforts for the department and organization if requested.
· Ability to travel (approximately 20%) which may include overnight and international travel to study meetings, other Orchard sites and vendor sites.