The Study Manager, Clinical Operations will be accountable for managing clinical operation activities for approximately 2 to 3 clinical trials. This person will drive strategic clinical trial operational planning, clinical studies day to day activities including budget management, ensuring on time delivery of main clinical milestones, and patient safety and data integrity.
Requirements
- 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.
- 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.
- 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.
- 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.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
