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About Anumana:
Unlocking the language of the heart. Anumana is a new AI-driven company formed by nference and the Mayo Clinic, delivering AI interpretation of ECG algorithms for early diagnosis and intervention. Anumana technology makes it possible to detect signs of illness that were once invisible and predict disease before specific symptoms appear. By unlocking the power of early detection, Anumana is empowering healthcare providers to accelerate needed patient treatment and care, resulting in enhanced patient quality of life and reduced overall healthcare costs. Anumana team members are recruited and hired by the parent company, nference, and deployed to work on Anumana.
Summary:
Anumana, a leading company in AI-driven healthcare solutions, is advancing the development of FDA-regulated, software-based ECG algorithms to predict heart disease. We are seeking a Senior Clinical Trial Associate (Sr. CTA) to join our growing clinical operations team. This role offers a unique opportunity to support the execution of multiple clinical studies, contributing to the advancement of innovative medical technology. As a Sr. CTA, you will play a key role in the planning, execution, and closeout of trials, ensuring compliance with regulatory requirements and the company’s operational standards. This position requires strong organization skills, attention to detail, and the ability to manage multiple tasks while adapting to evolving project and company priorities. You will work independently, identifying and addressing key tasks, and providing critical support to the clinical operations team. The role can be either hybrid or remote, reporting to the Head of Clinical Operations. The global HQ is in Cambridge, MA. No relocation or sponsorship is provided for this position.
Responsibilities Include:
- Assisting in planning and managing the operational aspects of clinical trials, including Contract Research Organization (CRO)/vendor oversight, to ensure project milestones and deliverables align with company goals.
- Supporting the development, review, and tracking of essential trial documents, such as informed consent forms, operational plans, Standard Operating Procedures (SOPs), and trackers.
- Managing the Trial Master File (TMF) for assigned trials, ensuring compliance with SOPs, Good Clinical Practice (GCP), and International Council for Harmonization (ICH) guidelines.
- Organizing and documenting internal and external meetings, including preparing agendas, minutes, and action items.
- Monitoring and updating clinical trial tracking tools for study progress, enrollment, data cleaning, and vendor activities.
- Liaising with clinical sites to maintain relationships, ensure compliance, and resolve site-related issues.
- Assisting with site start-up activities, subject enrollment, monitoring, and compliance with protocol and regulatory guidelines.
- Overseeing collection and review of site regulatory documents for accuracy and completeness.
- Assisting with the preparation and distribution of site contracts, budgets, and investigator payments.
- Supporting inspection readiness activities and ensuring TMF is audit-ready.
- Facilitating project management tasks, including tracking protocol compliance, study timelines, and quality standards.
- Working closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes.
Required Qualifications:
- Bachelor’s degree in science or health-related field.
- Minimum 3-4 years as a Clinical Trial Associate or Sr. Clinical Trial Associate, ideally within the medical device, pharmaceutical, biotech, or CRO sectors.
- Medical device experience strongly preferred, though pharma experience will be considered.
- Experience working in a start-up preferred.
- Experience working on international trials, in addition to US-based trials is a plus.
- Experience working on sponsor side preferred, though candidates with CRO or site experience will also be considered if they have sponsor-side experience.
- Thorough understanding of Good Clinical Practice, ICH, and regulatory requirements.
- Sound analytical and problem-solving skills.
- Exceptional organizational and time management skills.
- Excellent communication skills, both written and verbal.
- Act with consistent sense of urgency with acute attention to detail.
- Proficiency in Microsoft Office Suite, electronic data capture (EDC) systems, and electronic TMF systems.
- Prior experience with cardiovascular or AI trials is a plus.
Position includes competitive sick/vacation/holiday package, equity, health, dental, life insurance, STD, LTD and 401k plan.
Anumana is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, creed, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, military/veteran status, citizenship status, basis of genetic information, or any other group protected by law.
No sponsorship or relocation is provided for this role.
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