Remote Senior Manager

Summary

Join a dynamic early-stage company working to create selective medicines for cancer patients and lead clinical trial planning, execution, and data collection as Sr. Manager, Clinical Operations.

Requirements

• At least 5 - 7 years of Clinical Operations experience
• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 7+ years relevant experience within the biotech, pharmaceutical, or CRO industry
• Extensive knowledge of ICH-GCP guidelines
• Relevant experience managing early through late Phase clinical trials
• Experience in managing oncology global Phase 3 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

Responsibilities

• Lead and manage one or multiple clinical studies and demonstrate thorough knowledge of clinical operations’ project management
• Evaluates, selects, and ensures appropriate oversight of CROs and other external vendors
• Ensures clinical trials are executed according to scope of work, budget, timelines, KPIs, and goal
• 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
• Develop and manages 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; manages 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 the Clinical Data Manager to ensure timely and efficient database lock Participate in data review and reconciliation efforts
• Mentor junior team members by delegating study related responsibilities, overseeing, and supporting development plans
• Lead or co-lead department initiatives to support an expanding organization
• Travel may be required (10% – 15%)