Facilitating the integration of clinical functions, CROs, and vendors for the operational planning, execution, and reporting of clinical studies.
Participating in the generation of aggressive (but realistic) clinical study operational plans in alignment with clinical development objectives. Identification, assessment, and communication of clinical study risks.
Contribute to the process of identifying and selecting clinical study investigators, monitors, vendors including CROs.
Coordinating, monitoring, and reporting on clinical study execution from planning/initiation to close-out to meet study endpoints/objectives within clinical program scope, timelines, and budget.
Integrating external clinical vendors and contractors such as for patient recruitment, data management, and clinical sample analysis (PK, biomarkers, etc).
Planning and monitoring execution of clinical sample (PK/PD) collection, storage, analysis, and reporting in collaboration with clinical study sites, lab vendors, academic collaborators, and the study sponsor.
Facilitating and tracking clinical study documentation such as study protocol, eCRFs, ICFs, SAP, patient profiles, TMF, CSR, functional reports (PK, Biomarker, etc), monitoring visits etc. Contributing to the generation and maintenance of program documentations such as Investigator Brochures, Annual Reporting, etc. as needed.
Executing and monitoring the activities related to clinical drug product supply planning, shipment, and accountability (in collaboration with the study sponsor, CROs, and investigator sites).
Coordinates activities amongst sponsor, CRO/vendors, and investigator sites to ensure study-related record keeping/retention including TMF are implemented according to ICH, GCP, regulatory, institutional, and any other applicable requirements (e.g. records related to drug product, financial interests, any deviations/NTFs). Ensures that records and reports are accessible for any inspections or audits.
Managing cross-functional Clinical Study Teams and coordinating the clinical responsibilities/deliverables from Data Management/Operations, Safety, Regulatory, Biostats, Clinical Trial Supplies, and other clinical functions. Drafting meeting agendas with capturing and following up on meeting outcomes such as actions, issues, and decisions.
Hands-on cross-functional end-to-end trial and CRO/vendor management experience; independent critical thinker and self-starter: able to work with limited direction and part of a larger team; Experienced and knowledgeable in applying project management tools to plan, execute/monitor, report, and close-out of clinical studies on time and budget; detail-oriented and comfortable with managing all clinical study deliverables in the context of the overall clinical development plan.
10+ years of Clinical Operations/Management in a collaborative team environment demonstrating successful clinical study execution in alignment with overall clinical development objectives.
Experienced in managing clinical studies in a highly regulated environment: demonstrated successful execution of clinical operational deliverables including site monitoring and audits according to ICH and GCP/GMP guidelines/requirements.
Knowledgeable of Clinical Data Management/Operations deliverables: must be able to coordinate activities for identifying, tracking, and resolving clinical data issues/risks to ensure data quality/compliance and timely data cuts.
Demonstrated successful cross-functional clinical study operational planning, risk identification / assessment, execution/monitoring, and close-out/reporting.
Bachelor’s degree in a related/relevant field.
Expertise in virtual collaboration platforms such as TEAMS/SharePoint in addition to Microsoft Office Suite, MS Project, and Clinical Operations/Management related software (CTMS).