Braveheart Bio

Clinical Research

• 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.

Clinical Trial Manager

Compliance

• Manage the preparation, compilation, and submission of CTAs, including CTIS submissions and country-specific applications
• Ensure CTA packages include all required documents (e.g., protocol, IB, IMPD, ICFs) and meet regional and country-specific requirements
• Provide regulatory guidance on EU CTR, CTIS processes, and country-specific CTA requirements
• Manage health authority questions and sponsor responses to support timely approvals
• Support CTA maintenance activities, including substantial modifications, protocol amendments, IMPD updates, quality changes, annual updates, and notifications
• Track submission status and maintain inspection-ready documentation and regulatory archives
• Partner closely with Clinical Development and Clinical Operations to support global study start-up timelines
• Collaborate with CMC and Quality teams to ensure accurate and compliant IMPD and quality documentation
• Serve as a regulatory liaison across internal teams and external partners to ensure timely and compliant submissions across ex-U.S. markets

Clinical Trial Manager

Senior Manager, Regulatory Affairs