Location: London or Boston
Reporting to: Associate Director/ Director of Clinical Operations
Reporting to the Associate Director / Director of Clinical Operations, the Sr. Study Manager will be accountable for planning, execution management and closure of clinical studies. The Study Manager will accomplish this effort by working with the cross functional study team on day to day activites, both internally and with vendor teams to ensure the study is conducted according to the protocol and by following applicable guidance and regulations (ICH/GCP) while meeting on time delivery of clinical milestones as established by business goals. Responsible for clinical studies across phases 1 to 4, this person will be proactive in identifying study risks and leading problem solving efforts.
Responsibilities
- 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.
- Lead the cross functional study team, 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.
- Contributes to protocol development, including Clinical Operations feasibility assessments.
- Leads the evaluation and selection of required vendors, including contract and budget negotiation, task orders, change orders, invoice approval and financial reconciliation process.
- Responsible for day-to-day management of vendors working on assigned study, including setting expectations, training, oversight process, managing timelines and deliverables, and issue management.
- Provides 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, 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.
- Escalates medical issues to appropriate medical personnel.
- Management of study budget and provision of regular budget updates to Finance.
- In collaboration with 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
Requirements
Experience Required
- Strong expererience amp; knowledge of clinical project management in managing clinical studies from being to end
- Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
- Understanding of regulatory environment, GCP/ICH and compliance requirements for clinical research
- Experience working in an academic environment is a plus, as well as experience in rare disease areas and/or gene therapy
Education amp; skills
- BsC in life sciences
- Msc/PhD in life sciences is a plus
- Solid teamwork, organizational, communication, interpersonal, and problem solving skills; exercises good judgment when working cross functionally and with respect to Orchard confidential information
- ‘Can-do’ attitude and willingness to be flexible
- Fluent business English (oral and written)
Travel Requirements
- Requires approximately 20% travel, which may include overnight and international travel to study meetings, other Orchard sites, and vendor sites.