Manage multiple aspects of clinical studies working under the guidance and direction of the Clinical Program Lead.
Accountable for the delivery of project(s) to achieve agreed timelines, scope, quality, and budget.
Perform oversight of CRO and auxiliary vendors; identify risks and broker solutions.
Provide support and oversight managing the creation, maintenance and close out of TMF activities.
Ensure appropriate escalation of enrollment, site activation and data collection milestones.
Support the clinical team to ensure the completeness of clinical protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
Ensure site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are adhered to.
Support database lock by ensuring appropriate oversight of sites and by participating in data review/reconciliation efforts.
Coordinate with Clinical Supply Chain regarding drug forecasting and supply of drug product to sites.
Establish and maintain effective communication and collaboration with functional area peers to meet study/program objectives and support goals.
Lead or co-lead department initiatives to support an expanding organization.
Travel may be required (10% – 15%).

Requirements

Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 3+ years relevant experience in clinical operations within the biotech, pharmaceutical or CRO industry.
Extensive knowledge of ICH-GCP guidelines.
Relevant experience in early through late Phase clinical trials.
Knowledge of oncology clinical trials preferred.
Demonstrated cross-functional leadership fostering team spirit and team motivation.
Capability to challenge status-quo using risk management approach.

Benefits

Medical insurance
Dental insurance
Vision insurance
401(k) retirement savings plan
Generous paid time off (including a summer and winter company shutdown)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical operationsproject managementrisk managementdata reviewTMF activitiessite monitoringdrug forecastingclinical trial phasesoncology clinical trialsICH-GCP guidelines

Soft Skills

cross-functional leadershipteam spiritteam motivationeffective communicationcollaborationproblem-solvingoversightaccountabilityadaptabilityinitiative

Certifications

Bachelor’s degreescientific disciplinehealthcare discipline