Role Overview

With guidance from the Associate Director, 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 Associate Director, 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 Associate Director, 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.

Requirements

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 biotechnology industry
Experience as the regional lead for Europe, United States, Latin America, and/or APAC
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.

Braveheart Bio

Open Positions (1)

Management

Clinical Trial Manager