3,093 Clinical Trial Manager jobs in the United States

Key Responsibilities:

• Lead and manage all operational aspects of global clinical trials from study start-up through close-out
• Oversee study timelines, deliverables, and budgets to ensure milestones are met
• Coordinate with cross-functional teams, external vendors, and CROs to ensure high-quality study conduct
• Oversee site activation, clinical monitoring, data integrity, and adherence to protocol
• Conduct study-level risk assessments and ensure inspection readiness
• Manage safety and pharmacovigilance activities in collaboration with internal and external teams
• Lead internal and external study meetings; provide training to relevant stakeholders
• Contribute to the development of study-related documents and clinical study reports
• Perform other duties as needed to support successful trial execution

Qualifications:

• Bachelors degree in life sciences or a related (advanced degree preferred)
• Minimum of 8 years of clinical trial management experience, particularly in Phase 2/3 respiratory trials
• Demonstrated success in leading global trials and working with cross-functional and vendor teams
• Deep understanding of GCP, ICH guidelines, and global regulatory requirements
• Specific therapeutic experience in respiratory diseases, especially COPD , strongly preferred
• Strong project management, problem-solving, and communication skills
• Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel

Responsibilities: We are seeking a highly motivated and qualified individual to join our Clinical Department as a Clinical Trial Manager (CTM) and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The CMT will support ongoing RNA-based drug discovery projects in several therapeutic areas. The Clinical Trial Manager (CTM) is responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory.Requirements: BS/MS in life and health sciences (biology, pharmacology, pharmaceutical sciences or equivalent). 5+ years of combined managing/monitoring Phase 1, 2, or 3 clinical trials. Ability to work across global time zones (including EU, APAC). Experience in performing clinical site monitoring visits, including remote visits. Experience in CRO/Vendor management (domestic/international) monitoring of budget scope. Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements. Proficiency working with Microsoft Office Suite Products, EDC, IRT. Ability to travel domestically and internationally if necessary.

• Develop and manage clinical trial protocols and associated documentation.
• Select, train, and manage investigational sites and clinical investigators.
• Oversee study conduct, ensuring compliance with GCP and regulatory requirements.
• Monitor study progress, budget, and timelines.
• Manage data collection, cleaning, and analysis.
• Liaise with regulatory authorities and ethics committees.
• Identify and mitigate risks associated with clinical trials.
• Coordinate with internal departments (e.g., drug supply, biostatistics) and external vendors.
• Prepare regulatory submission documents and reports.
• Ensure patient safety and data integrity throughout the trial.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Master's or advanced degree preferred.
• Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotech industry.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements (FDA, EMA).
• Proven experience in managing multiple clinical trials simultaneously.
• Strong project management, organizational, and leadership skills.
• Excellent communication, interpersonal, and problem-solving abilities.
• Proficiency in clinical trial management software and EDC systems.
• Experience in Phase II and Phase III oncology trials is a significant advantage.
• Ability to work independently and as part of a team in a fast-paced environment.

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship productan AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFR CT Analysisprovides a color-coded, 3D model of a patients coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFR CT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis).Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 400,000 patients worldwide.

The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

Job Responsibilities:

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• Perform other duties as required for successfully completing studies, as necessary

Skills Needed:

• Ability to work in a smaller team environment with a willing, all hands on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint

Educational Requirements & Work Experience:

• Bachelors degree in science or health related field
• Demonstrated 5 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus

Travel required: up to 25%

A reasonable estimate of the base salary compensation range is $95,000 to $140,000 (for San Francisco Bay Area) and cash bonus. #LI-IB1; #LI-Hybrid

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.

Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.

Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with @heartflow.com and B) the position described is found on our careers site at .

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