Braveheart Bio
Healthcare
SeniorClinicalTrialManager
“Senior Clinical Trial Manager at Braveheart Bio. Skills: Clinical Trial Management, CRO and Vendor Management, Study Execution Oversight, Regulatory Compliance. End-to-end operational delivery of a study. Strategic oversight of study execution”
What You'll Achieve.
End-to-end operational delivery of a study; Ensure alignment with overall program strategy; Drive appropriate follow-up actions based on study metrics; Ensure efficient and timely study start-up across regions; Ensure study procedure conduct is in accordance with the study protocol, SOPs, regulatory requirements, and study plans; Ensure performance aligns with study expectations, timelines, budget, and quality standards; Ensure inspection readiness and compliance with GCP, SOPs, and regulatory requirements; Identify trends and drive appropriate follow-up actions; Contribute to Clinical Operations process improvements and departmental initiatives
Industry & Context.
Proactively identifying risks; Escalating critical issues with proposed mitigation strategies; Problem-solving skills; Ability to anticipate risks and implement mitigation strategies
May require domestic or international travel up to 25% (as needed), Valid travel documents must be obtainable
What They're Looking For.
Must Have
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials, Familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency is a plus), Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity, Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
Nice to Have
study lead experience, experience with CRO and vendor management, including oversight of performance and deliverables, direct people management experience is a plus
What You'll Do.
End-to-end operational delivery of a study
Strategic oversight of study execution
Financial accountability
Cross-functional alignment
Overseeing day-to-day execution from start-up through close-out
Monitoring study metrics
Overseeing and supporting regional study execution
Overseeing CRO and vendor activities
Contributing to or owning the development of key study documents
Ensuring inspection readiness and compliance
Participating in study reviews
structured study updates
Mentoring and providing day-to-day guidance to junior team members
How You'll Work.
Team & Collaboration
Collaboration with other study leads across the program; Cross-functional coordination across Clinical, Regulatory, Data Management, Safety, and other stakeholders; Collaborative, team-oriented approach
Communication Scope
Excellent communication skills; Written and verbal communication skills; Presentation skills
Process & Methodology
Drive study timelines, deliverables, and operational plans, Manage study execution from start-up through close-out, Oversee CRO and vendor activities, Support budget tracking and vendor financial oversight
Applying for this Senior Clinical Trial Manager role?
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