PATH’s Essential Medicines conducts vaccine and drug development, including associated technology research and vaccine introduction activities in the following disease areas: malaria, diarrheal diseases and polio, respiratory tract infections and meningitis, HPV, and vector-borne viral diseases, as well as in the cross-cutting area of Maternal Immunization.  The EM Clinical Functional Team provides leadership and support to the clinical activities conducted by various programs developing vaccines and drugs for implementation in low-resource settings, including the design of clinical development plans, protocols and related documents, implementation of clinical trials, monitoring and oversight of all trial activities, and support for regulatory submissions leading to local registration and WHO prequalification of new vaccines.

The Senior Clinical Research Manager will be responsible for independently providing operational oversight of the planning, implementation, and close-out of vaccine clinical trials conducted within the Center for Vaccines, Innovation, and Access (CVIA) program and will be part of the CVIA Clinical Team.

Primary Responsibilities:

Trial Management

• Provide overall study start-up, implementation, and close-out leadership for study trials.
• Lead development and maintenance of clinical study timelines and clinical trial risk identification and management.
• Lead development and review of Clinical Protocols, ICFs, CRFs, SOPs, and other trial related documents.
• Lead development of central ethical submission packages and annual review submissions, including version control/tracking across multiple ethics committees.
• Contribute to Scientific Merit Review packages.
• Develop and contribute to appropriate study plans (e.g., monitoring, pharmacy, data management, laboratory, manual of procedures, communication, etc.).
• Oversee protocol implementation by reviewing progress reports from CROs, monitoring, and data quality reports, and audit reports as needed.
• Identify and participate in the resolution of operational compliance and logistical problems impacting trials quality.
• Lead the maintenance, and final archiving of the Trial Master Files following ICH-GCP and PATH internal procedures, including maintaining an audit-ready state.
• Oversee procurement, import, and delivery of clinical trial supplies (including Investigational Product) according to trial protocol specifications.
• Oversee development of systems for tracking specimens from point of collection to delivery to central laboratories coordination according to trial protocol specifications.
• Oversee clinical trial registry postings.
• Lead or contribute to project kick off meetings and Investigator Meetings.

Site Management

• Plan and conduct international site visits to help establish trial activities and evaluate operations.
• Lead site initiation visits and ascertain site readiness for study start.
• Oversee site implementation, including the establishment of recruitment/retention plans and materials, as well as tracking enrollment and visits.
• Oversee establishment and maintenance of Investigator Site File.
• Verify adequacy of site staff experience and training, coordinate additional training as needed, including GCP and Site Initiation Visits.
• Conduct and document Sponsor-level oversight or monitoring visits, as needed.
• Plan and coordinate site audits, including defining, scheduling, assessing, and evaluating eventual outcomes, and supporting remedial plans.

Vendor Management

• Oversee selection and qualification of clinical trial sites and CROs
• Manage contractual activities of clinical sites and CROs, including outlining partner roles and responsibilities and technical milestones triggering payments.
• Oversee finalization of monitoring reports and tracking of action items to completion.

General

• Lead study-specific meetings (including the development of agendas, minutes, action items, and decisions) and maintain study-related documentation.
• Integrate seamlessly across a cross-functional study team in implementing trials on time and with high quality, including with project, data management, biostatistics, laboratory, CMC, medical, and regulatory leads.
• Demonstrate a sense of urgency in delivering on trial milestones completed with high quality and in a timely manner.

Required Experience

• Master’s degree or higher in a related scientific discipline (i.e., a core biological science, epidemiology, public health, etc.), or a degree in nursing or medicine; ACRP or SoCRA certification preferred.
• At least 10-years of prior experience supporting clinical research studies across all trial phases (Phase 1 to 4) and stages (start-up through close-out).
• Experience working in vaccines is required.
• Experience working both on the Sponsor and vendor sides preferred.
• Experience managing trial sites and Contract Research Organizations (CROs).
• Experience with international clinical research in low-resource countries.
• Expertise in international regulatory requirements, procedures, and policies
• Expertise in GCP, ICH, and other Guidance documents and policies related to clinical trial operations.
• Ability to analyze information, review reports, and prioritize actions.
• Ability to work well in a team environment, both as a leader and a contributor.
• International and domestic travel 15-20%.
• Open, engaging, collaborative, and transparent work style.
• Global perspective and mindset; ability to work effectively with colleagues from other cultures.
• Excellent computer skills.
• Strong verbal and written communication skills.