Marbles Health
Location
Gurgaon | India
Job description
We're looking for a rockstar to join a rapidly growing medical device company. You will be a part of the founding team of Marbles Health, working closely with the founders, and be responsible for handling clinical trials across India, EU, USA, and quality management for the medical device.
Key Responsibilities: Trial Execution: Assist in the planning and execution of clinical trials by providing regulatory and quality assurance expertise to project teams. Facilitate the development and review of study protocols, informed consent forms, and other trial-related documents to ensure accuracy and compliance. Coordinate with clinical trial sites, clinicians and researchers to ensure timely initiation, monitoring, and close-out activities in accordance with regulatory expectations. Quality Assurance Oversight: Develop and maintain quality management systems (QMS) to support clinical trial operations, including document control, training, and deviation management. Conduct internal audits and inspections to assess compliance with standards, and regulatory requirements. Collaborate with cross-functional teams to identify areas for process improvement and implement corrective and preventive actions (CAPAs) as needed. Data Integrity, Training and Reporting: Oversee data management activities, including trial data entry, validation, and reconciliation, to ensure the integrity and accuracy of clinical trial data. Generate and distribute quality metrics, compliance reports, and trend analyses to internal stakeholders and authorities as required. Providing training and updates to internal teams on regulatory changes and requirements. Also responsible for communicating with external regulatory bodies and agencies. Qualifications: Bachelor's degree in life sciences, pharmacy, nursing, or related field. 2+ years of experience in working with a clinical research organization, regulatory affairs, or quality assurance within the pharmaceutical or biotechnology industry. Proficiency in document management systems, electronic data capture (EDC) platforms, and quality management software preferred. Excellent analytical, problem-solving, and communication skills with a keen attention to detail. Ability to collaborate effectively across multidisciplinary teams and prioritize tasks in a dynamic environment.Job tags
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