Braveheart Bio

Braveheart Bio

Clinical Trial Management Associate

San Francisco, CA or Remote or Hybrid

Sponsorship not specified$100k-$135kDetected 59 days ago
ExcelClinical TrialsFDA RegulatoryLeadershipCommunicationProblem SolvingTime ManagementAdaptabilityMicrosoft Office

About 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.)

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.
  • Maintain internal Clinical Operations systems, trackers, and document repositories. Prepare and distribute study status updates and meeting minutes and ensure vendors do the same.
  • 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.
  • 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.

Requirements

  • Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
  • valid travel documents must be obtainable

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 interdepartmental strategic initiatives under general supervision
  • High energy level, personal productivity, creativity and commitment
  • Highly adaptable team-player; eager to learn
  • Strong written and verbal communication skills with a collaborative, team-oriented approach

Compensation

  • This role is eligible for a competitive total rewards package, including an annual bonus, equity, and a comprehensive benefits offering.
  • 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.
  • $100,000 - $135,000

Company info

  • 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.)
  • 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.

Equal opportunity

  • We are an equal opportunity employer.

Visa & Work Authorization

  • Accountable for study level tracking at Sponsor (e
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