Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management. Collaborate with cross-functional clinical study team to support clinical study delivery.
Evaluates, and ensures appropriate oversight of CROs and other external vendors.
Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support goals.
Identify risks and propose solutions to facilitate clinical studies.
Responsible for review and oversight of the study-level budget(s) and demonstrates accountability for the management of the budgets through managing the review and approval of contracts and/or work order changes; contribute to budget forecasting and accruals in collaboration with finance.
Oversee and manage the creation, maintenance, QC and close out of TMF activities.
Ensure appropriate oversight of enrollment, site activation and data collection milestones.
Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
Collaborate with Data Management to ensure timely and efficient database lock. Participate in data review and reconciliation efforts.
Lead or co-lead department initiatives to support an expanding organization.

Requirements

At least 5 - 7 years of Clinical Operations experience.
Bachelor’s degree or higher in a scientific or healthcare discipline preferred and relevant experience within the biotech, pharmaceutical, or CRO industry.
Extensive knowledge of current ICH-GCP guidelines.
Relevant experience managing early through late Phase clinical trials.
Demonstrated cross-functional leadership fostering team spirit and team motivation.
Capability to challenge status-quo using risk management approach.
Able to thrive in a remote/virtual environment.

Benefits

medical, dental, and 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 operations project managementbudget managementrisk managementdata reviewdatabase lockTMF activitiesclinical trial executioncontract managementKPI managementclinical study documentation

Soft Skills

cross-functional leadershipteam collaborationcommunicationproblem-solvingaccountabilityteam motivationadaptabilityinitiativeoversightstakeholder engagement