Roivant Sciences is hiring a
Clinical Trial Manager, Remote - United States

Summary

The Clinical Operations Senior Clinical Trial Manager will work closely with the Director of Clinical Operations to manage operational aspects of clinical trials. The role involves timeline oversight, vendor management, study planning, and ensuring quality data collection. The candidate should have 5-7 years of experience in global Phase 1-3 clinical trials with recent experience in study start-up, a bachelor's degree in the life sciences or related field, and the ability to travel up to 25%.

Requirements

• Minimum 5-7 years experience in managing and leading clinical trial activities in global Phase 1-3 clinical trials with recent experience in study start up
• Bachelor’s degree or equivalent in the life sciences or related field required
• Experience in a small, fast-paced start up biotech is a plus
• Experience with CRO and vendor management; holding CRO and vendors accountable for timelines and milestones
• Must be willing to travel up to 25%, domestically and internationally to conferences, vendor meetings, and site visits
• Ability to deal with multiple priorities and aggressive timelines
• Proven ability to independently manage multiple projects/tasks
• Strong Oral and written communication skills

Responsibilities

• Work closely with the Director of Clinical Operations to manage operational study-level timeline, cost, and quality deliverables
• Lead the development of the clinical study plan including critical path activities
• Participate in CRO and Vendor Selection Process
• Oversee and drive clinical trial vendors, maintaining detailed understanding of timelines and tracking towards key study milestones
• Develop/update critical study documents as needed
• Coordinate with the CRO to prepare/execute meetings including vendor kick off, study team meetings, regional team meetings, Investigator meetings and training
• Independently oversee CRO and vendor Clinical Study Plans to a quality completion, including Study Monitoring Plans, Site Selection Plans, Risk Management Plans, etc
• Review CRO generated reports including monitoring visit reports, protocol deviation reports and site metrics reports to proactively identify and escalate areas of concern
• Lead and conduct internal cross functional Study Team Meetings
• Work closely and collaborate with internal cross functional colleagues to ensure early study milestones for regulatory submissions are met
• Triage, resolve, or escalate study issues/risks mitigations to the operations management team or additional stakeholders as appropriate
• Monitor study budget against trial progress and escalate deviations and reconcile with finance on an ongoing basis
• Mentor junior team members
• Coordinate and facilitate clinical document revisions (plans, memos, notes to file)
• Participate in any training meetings and train CROs/vendor staff as required
• Perform User Acceptance Testing for vendors and systems such as EDC, IRT, ePRO, etc
• Provides support to Clinical Operations team as needed