Clinical Trial Manager

Braveheart Bio; United States; Remote; USD 140,000 - 170,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits

Job summary

Braveheart Bio is seeking a Clinical Trial Manager to lead regional start-up activities for a global Phase 3 program. You will manage site initiation, vendor coordination, and regulatory submissions across Europe, reporting to Clinical Operations.

The role offers remote work with up to 25% travel, competitive total rewards including equity, and a comprehensive benefits package.

Qualifications

• 4+ years in clinical trial operations or equivalent.
• Experience as regional lead for Europe preferred.
• Knowledge of FDA/EMEA regulations, ICH and GCPs is desirable.

Responsibilities

• Manage day-to-day regional activities including site selection, start-up, maintenance and close-out.
• Coordinate with CROs and vendors to initiate study timelines.
• Review regulatory documents and ensure compliance with SOPs and protocols.
• Provide regular study updates to stakeholders and maintain study databases.

Skills

Clinical Trial Mgmt

Regulatory knowledge

GCP guidelines

Vendor management

EU start-up lead

Site start-up

Data review liaison

Education

BS/BA in science

RN (certificate optional)

Tools

MS Office

Job description

About us:

Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.

With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.

The role:

The Clinical Trial Manager(CTM)is a key member of the Clinical Operations team and willreport intotheClinical Program Manager, Clinical Operations, partnering closelyonthe start-up and initiation of a global Phase 3 program. The primary responsibilitiesof the CTM will be regionalstudy managementof theEUand vendormanagement.

Key responsibilities:

• With guidance from theClinical Program Manager,ClinOps, responsibilityfor day-to-day activities within a region orregions, including siteselection, 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.
• AssistClinical Program Manager,ClinOpswith oversight of CRO and set-up of vendors asrequired, including liaising with Global CRO to ensuretimelyinitiation of study.
• Day-to-day contact with counterpartsat CRO and/or trial sites, including daily review and identification of potential issues or problems that must be communicated/escalated directly toClinical Program Manager,ClinOps.
• Reviewsite Informed Consent Forms and elevate toappropriate individuals, as needed.Assistwith regulatory submission package reviewfor submissions withinregion.
• Proactivelyidentifypotential operational challenges and, in collaboration with senior team members, provide solutions to ensure study executionremainson track.
• Perform accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure study procedure conduct isin accordance withSOPs and protocolprocedures andreview routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, asrequired.
• With guidance,mayassistin review of protocols, informed consents, and case report forms,monitoringplans, abstracts, presentations,manuscriptsand clinical study reports. Mayassistin compilation of investigator brochure appendices under close supervision.
• Review of trip reports generated by CRO CRAs for trends and quality issues.
• Review protocol deviations andmonitor fortrends.
• Coordinate review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies.
• Provide regular study updates to theappropriate internalstakeholders.
• Maintain internal Clinical Operations databases and document repositories.
• Perform administrative dutiesin a timely manneras assigned.
• Guide and support junior team members, ensuring alignment on deliverables, timelines, and quality standards.

Required experience & skills:

• At least 4+ years of relevant experiencewitha BS or BA in a relevant scientific disciplineoran RN (2-or 3-year certificate)
• Relevant clinical trial experience in the pharmaceutical or health care industry.Experience as the regional lead for Europestrongly preferred
• Excellent attention to detail, interpersonal and presentation skills area 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 excelproficiencya plus)
• Must be able toparticipatein departmental or interdepartmental strategic initiatives under general supervision
• High energy level, personal productivity,creativityand 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.

Salary Range:

$140,000 - $170,000

This role is eligible for a competitive total rewards package, including an annual bonus, equity, and a comprehensive benefits offering.

We are an equal opportunity employer.

We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.

Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires.

To learn more about E-Verify please review this poster.