Clinical Research Lead (Medical Device)

Job Description

Job Title: Clinical Research Lead Location: Bangalore Company: Janitri Innovations Pvt. Ltd. About Janitri Innovations Pvt. Ltd.: Janitri is a social enterprise with a vision to create a world where no mother or newborn dies during pregnancy, birth, or post-delivery. We innovate and develop medical devices and technologies to improve maternal and newborn health. Our focus is on bringing impactful solutions to healthcare through continuous research and clinical studies on maternal-fetal health monitoring technology. Job Summary: The Clinical Research Lead will take charge of leading clinical studies from initiation to completion. This role involves overseeing clinical trials, coordinating with hospitals and stakeholders, ensuring the quality of data collection and analysis, and leading research initiatives. The ideal candidate will have experience in clinical research, especially within the medical device sector, and be skilled in designing studies, managing execution, and ensuring scientific rigor. Key Responsibilities: Leadership in Clinical Studies: Lead the execution and coordination of ongoing and new clinical studies in collaboration with hospitals, PIs (Principal Investigators), and research teams. Oversee all phases of clinical studies from concept development, protocol design, and sample size calculation to execution, ethics approval, and data analysis. Study Design & Execution: Design clinical research protocols in accordance with scientific guidelines and regulatory standards. Work closely with the study team to ensure smooth execution of clinical trials, including participant recruitment, data collection, and study monitoring. Data Analysis & Reporting: Lead data analysis and generate reports using statistical tools (e.g., SPSS, SAS, Excel, Matlab, Python). Provide insights through data interpretation, ensuring data integrity, and maintaining detailed records of study findings. Stakeholder Management: Regularly engage with key stakeholders such as hospital teams, public health experts, and internal staff to track progress, resolve issues, and drive study success. Facilitate meetings and discussions with stakeholders to ensure alignment on study objectives and timelines. Regulatory & Ethics Coordination: Ensure all studies comply with regulatory guidelines and secure necessary ethics approvals. Liaise with ethics boards, hospitals, and government authorities for study submissions and compliance requirements. Manuscript Writing & Publications: Lead the writing and publication of scientific papers and reports based on research findings. Collaborate with the public health team on research publications and ensure high-quality submissions to relevant journals. Team Collaboration & Mentorship: Mentor junior clinical research staff and provide guidance on study design, execution, and data analysis. Collaborate with cross-functional teams (product, public health, and regulatory) to align clinical study outcomes with company goals. Skills, Knowledge, and Experience: Minimum 4 years of experience in clinical research, with at least 2 years in a leadership role within the medical device or healthcare industry. Strong understanding of clinical research methodologies and statistical analysis. Proficiency in statistical analysis software (SPSS, Matlab, Python, SAS, Excel) and other relevant tools. Experience in study design, protocol writing, sample size calculation, and data management for clinical trials. Strong project management skills with a focus on delivering quality results on time. Proven experience in coordinating with ethics boards and securing regulatory approvals. Excellent communication, interpersonal, and leadership skills with proficiency in English. Experience in writing and publishing research papers in scientific journals. Why Join Us? This role offers the opportunity to lead impactful research that will directly contribute to improving maternal and newborn health outcomes. If you are passionate about clinical research and want to be part of an innovative team making a difference, we encourage you to apply.