Clinical Trial Management Associate

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 Management Associate (CTMA) is a key member of the Clinical Operations team and will partner closely with the Clinical Trial Manager (CTM), Senior CTM, and Associate Director, Clinical Operations. The CTMA will support the execution of a global Phase 3 program, with a primary focus on study coordination, documentation, and operational support. Under the supervision of the Associate Director, Clinical Operations or the Senior CTM, the CTMA may manage sites within a region (e.g., EMEA or Americas) and/or vendors (e.g., IRT, eCOA, etc.).

Key responsibilities:

• Provide operational and administrative support for day‑to‑day clinical trial activities, including study start‑up, maintenance, and close‑out.
• Support site start‑up activities, including tracking of site start‑up components and assisting with site activation readiness.
• Accountable for study level tracking at Sponsor (e.g., monitoring visit tracking, sample tracking, patient tracking, site activation tracking, etc.).
• Act as a point of contact for CROs and study sites for routine communications and follow‑ups, including escalations and engagement. Assist with coordination of investigator meetings and study‑related communications.
• Track study timelines, deliverables, and key milestones; proactively follow up on outstanding items.
• Maintain internal Clinical Operations systems, trackers, and document repositories. Prepare and distribute study status updates and meeting minutes and ensure vendors do the same.
• Assist with vendor coordination and oversight, including vendor set‑up, performance, and deliverable tracking. May assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.
• Support review of study documents (e.g., informed consent forms, regulatory packages) and route for approval.
• Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and compliant manner; create, maintain, and close out TMFs; play a central role in setup, conduct, and close out of ancillary services; facilitate quality reviews and support trending activities.
• Facilitate and/or assist in review of CRO monitoring trip reports for completeness and consistency and, under supervision of other Operations personnel, may complete co‑monitoring activities.
• Track protocol deviations and support trending activities.
• Support data review activities, including tracking queries and assisting with data listings review.
• Perform administrative duties in a timely manner as assigned.
• Adhere to Clinical Operations processes and SOPs.

Required experience & skills:

• BS or BA in a relevant scientific discipline or RN (2‑ or 3‑year certificate).
• Minimum of 2 years of relevant clinical trial experience.
• Clinical trial experience in the pharmaceutical or biotechnology 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…