Clinical Trial Manager

Braveheart Bio is a clinical-stage biopharmaceutical company developing therapies for hypertrophic cardiomyopathy and other serious cardiovascular diseases. The Clinical Trial Manager will support the start-up and initiation of a global Phase 3 program, with primary responsibility for regional study management in Europe and vendor oversight. The role coordinates clinical trial sites and CROs, reviews regulatory and study documentation, monitors operational quality, and supports clinical study reporting.

Responsibilities

With guidance from the Clinical Program Manager, ClinOps, responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities. With guidance, may serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs

Assist Clinical Program Manager, ClinOps with oversight of CRO and set-up of vendors as required, including liaising with Global CRO to ensure timely initiation of study

Day-to-day contact with counterparts at CRO and/or trial sites, including daily review and identification of potential issues or problems that must be communicated/escalated directly to Clinical Program Manager, ClinOps

Review site Informed Consent Forms and escalate to appropriate individuals, as needed. Assist with regulatory submission package review for submissions within region

Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track

Perform accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure study procedure conduct is in accordance with SOPs and protocol procedures and review routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required

With guidance, may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochure appendices under close supervision

Review of trip reports generated by CRO CRAs for trends and quality issues

Review protocol deviations and monitor for trends

Coordinate review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies

Provide regular study updates to the appropriate internal stakeholders

Maintain internal Clinical Operations databases and document repositories

Perform administrative duties in a timely manner as assigned

Guide and support junior team members, ensuring alignment on deliverables, timelines, and quality standards

Preferred

Experience as the regional lead for Europe strongly preferred

Regional Lead Experience

Benefits

Annual bonus

Equity

A comprehensive benefits offering

Remote work

Company

Late-stage biotechnology developing hypertrophic cardiomyopathy therapeutics

San Francisco, California, USA

https://www.braveheart.bio/

Founded in 2025

51-200 employees

Qualifications

At least 4+ years of relevant experience with a BS or BA in a relevant scientific discipline or an RN (2- or 3-year certificate)

Relevant clinical trial experience in the pharmaceutical or health care industry

Excellent attention to detail, interpersonal and presentation skills are a critical asset

Excellent organizational, problem-solving and time management skills

Must be familiar with routine medical/scientific terminology

Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable

Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus)

Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision

High energy level, personal productivity, creativity and commitment

Highly adaptable team-player

Strong written and verbal communication skills with a collaborative, team-oriented approach

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

This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable

Experience as the regional lead for Europe strongly preferred

Required skills

Clinical Trial Management, Regional Clinical Operations Management, CRO and Vendor Management, Clinical Trial Regulations (FDA/EMEA), ICH Guidelines, Clinical Practice (GCP), Medical and Scientific Terminology, Microsoft Word, Microsoft PowerPoint, Microsoft Excel

Experience

4+ years