Reporting to the Director of Clinical Operations, this individual contributes to the development and implementation of strategic direction of clinical trials, acts as study team lead for Clinical Operations and is responsible for delivery of all clinical trial operational activities, across one or more studies.
Accountable for overall management of clinical trials, including providing strategic direction to the study team, to meet corporate goals and timelines
Collaborate with the Clin Development to assess study progress, ensure proper study conduct and adherence to the protocol
Central role maintaining relationships with other internal functions, strategic partners and CROs
Oversee functional deliverables to support program objectives, identify risks to study timelines, propose mitigations, and implement solutions with team and management support
Communicate program status, cost, and issues to senior management
Monitor global regulatory intelligence for international industry practices for operational efficiency and compliance
Responsible for the coordination of team meetings, as assigned, with both internal and external partners
Serve as a clinical trial lead for one or more trials and responsible for implementation, planning, and execution of clinical trial activities
Cultivate and maintain strong relationships with investigators, and trial site managers and other site staff, as applicable
Participates in the selection of vendors and manages their activities.
Organize investigator meetings, as needed
Coordinate timely data review to identify trends and discrepancies
Responsible for all aspects of site management from feasibility, selection, start-up, maintenance, and close out
Select, assess, and approve sites for activation
Contribute to study budget, including regular forecasting and internal reporting
Review invoices against scope of work and work completed to date, and to identify and communicate variances
Responsible for management of CRO and vendors to support clinical operations contracted for the assigned study/studies

Requirements

BA/BS required in a scientific / medical field, or equivalent work experience
8- 10 years of industry experience
Demonstrated ability to successfully manage and support clinical trial deliverables from start-up through close-out, including all financial tracking and reporting activities.
Understanding of clinical trial design, protocol development and review
Extensive experience with cross-functional leadership and clinical teams, including data review, database lock and study reporting activities
Vendor management experience required given many accomplishments will come from external resources
Experience in oncology studies is preferred
Experience in maintenance of a submission ready eTMF required
Experience in Quality Assurance, SOP (Standard Operating Procedure), and study plan writing, CAPA (corrective and preventative action) preparation and closure
Experience with investigator-initiated and industry-sponsored studies
Strong knowledge of GCP (Good Clinical Practice) and working knowledge in ICH (International Conference on Harmonization) (International Conference on Harmonization) GCP (Good Clinical Practice) E6 R2 regulations
Knowledge of GDPR (General Data Protection Regulation) and how to apply appropriate practices to clinical trials
Leadership ability and further potential to build relationships in a matrix environment, ability to multi-task in a dynamic and fast paced environment
Excellent interpersonal, written, and verbal skills required
Working experience / knowledge of timeline management tools (e.g., Smartsheet)

Benefits

annual bonus
stock-based long-term incentives
medical, dental, and vision benefits
retirement
wellness stipend
flexible time off

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical trial managementclinical trial designprotocol developmentfinancial trackingdata reviewvendor managementeTMF maintenanceQuality AssuranceSOP writingGCP

Soft Skills

leadershipinterpersonal skillscommunication skillsrelationship buildingmulti-taskingorganizational skills