Clinical Research Manager

Key Responsibilities:  Clinical Trial and RWE Study Management: o Design, plan, and manage clinical trials and RWE studies from initiation to close-out. o Develop study protocols, informed consent forms, and other essential documentation. o Ensure alignment with company objectives and compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and regulatory requirements (FDA, EMA, etc.). o Manage study timelines, budgets, and resources to meet clinical milestones and research goals. o Collaborate closely with data scientists to ensure the appropriate application of advanced data analytics techniques to extract meaningful insights from clinical data.  Scientific Writing and Documentation: o Author and review scientific reports, clinical study reports, abstracts, and peer-reviewed manuscripts. o Contribute to the preparation of documents for regulatory submissions, including protocols, informed consent forms, and Investigator's Brochures. o Ensure that all documentation follows scientific integrity, clarity, and accuracy guidelines. o Collaborate with internal and external stakeholders to ensure high- quality scientific communication.  Regulatory and Ethical Compliance: o Prepare and submit regulatory documents to ethics committees and institutional review boards (IRBs). o Stay updated on regulatory and industry developments, ensuring studies comply with current legal and ethical guidelines. o Maintain proper documentation and ensure all study-related materials are archived according to regulatory and company standards.  Data Management and Reporting: o Oversee data collection, quality control, and statistical analysis, particularly in collaboration with study sites and data scientists. o Ensure accurate and timely reporting of clinical trial and RWE study outcomes. o Present findings at internal meetings, external conferences, and publish in scientific journals.  Team Leadership and Collaboration: o Lead and mentor clinical research coordinators, associates, and scientific writing staff. o Collaborate with external clinical investigators, study sites, and other vendors to ensure seamless study execution. o Work with cross-functional teams, including medical, regulatory, data management, and data science teams to drive study success.  Risk Management and Problem Solving: o Identify and mitigate risks during clinical trials and RWE studies to prevent delays or non-compliance. o Proactively address operational and technical issues related to trial execution.  Stakeholder Communication: o Serve as the primary point of contact for study sites, investigators, external partners, and regulatory bodies. o Provide clear and concise updates on study progress to senior management, regulatory authorities, and other stakeholders. o Collaborate with key opinion leaders (KOLs), medical affairs teams, and data scientists to align research with strategic objectives.  Other Tasks: o Carry out additional tasks and responsibilities as assigned by the reporting manager, contributing to the overall success of the clinical research team and project objectives. Qualifications:  Bachelor or Masters degree in in Life Sciences, Nursing, Pharmacy, Dental Surgery (BDS) or a related field.  Minimum of 6+ years of experience in clinical research, with 2+ years in a managerial role.  Demonstrated experience in conducting RWE studies. Clinical trials and observational research.  Proven track record in scientific writing, including authoring manuscripts, reports, and regulatory submissions.  Strong knowledge of clinical trial regulations, ICH-GCP, FDA, EMA, and other relevant regulatory requirements.  Experience in collaborating with cross-functional teams and leveraging advanced data analytics is highly desirable.  Excellent project management and organizational skills.  Certification in clinical research or scientific writing is a plus. Key Competencies:  Expertise in clinical research and Real World Evidence methodologies.  Strong analytical skills and ability to interpret complex datasets in collaboration with data scientists.  Excellent scientific writing and communication skills, with the ability to translate research findings into publications and reports.  Leadership and mentoring abilities for managing cross-functional research teams.  Detail-oriented and highly organized, capable of managing multiple projects simultaneously. About Dozee () Dozee, India’s #1 AI-based contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) , continuously monitors patients and provides early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in Non-ICU wards. A true "Made in India for the World" solution, Dozee introduced the world’s first non-contact blood pressure monitoring system. Trusted by leading healthcare providers in India, the USA, and Africa, Dozee is transforming patient care by improving outcomes and reducing costs. Dozee is adopted by 200+ hospitals and monitors 10000+ beds . Large hospitals like Apollo, Breach Candy, P D Hinduja, Wockhardt, SRM and many more have adopted Dozee Pan India among others. A third-party impact analysis, conducted by Sattva consulting to assess the impact of implementing the Dozee platform in public hospitals in India, has the following key highlights: 80% less time taken by nurses in vital capturing. 144 lives saved yearly for every 100 Dozee bed by lifesaving alerts ALOS for ICU reduced by 1.3 days . Saving of INR 2.7 Cr / year for every 100 Dozee beds Foundation : October, 2015 Founders : Mudit Dandwate, Gaurav Parchani Headquarter : Bangalore, India | Houston, USA Key Investors & Backers : Prime Ventures, 3one4 Capital, YourNest Capital, Gokul Rajaram, BIRAC (Department of Biotechnology, State Bank of India, and Dinesh Mody Ventures. Stage : Series A+ Team Strength : 280+ Business : Providing Continuum of care with AI-based contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) for Hospitals and Home. Certifications & Accreditations : ISO13485:2016 Certified, ISO27001:2013 Certified, CDSCO Registered, FDA510K Cleared for the flagship product Dozee Vitals Signs (VS) measurement system and SOC2 TypeII Certified Achievements : Awards Forbes India 30 under 30 Forbes Asia 100 to Watch BML Munjal Award for Business Excellence using Learning and Development FICCI Digital Innovation in Healthcare Award Anjani Mashelkar Inclusive Innovation Award 2020 Marico Innovation For India Award Republic India - Emerging Healthcare Technology Award TimesNow Bharat AI Healthcare Innovation Award Financial Express HealthcareTechnology Leader of the Year ET Innovation award Gold Award in the @Medicall Made in India Healthcare Innovations Awards CXO Innovations award for AI Driven Remote Patient Monitoring Dataworld award for best use of data science for impact Tech Start-up of the Year 2019 Award at Assocham's Emerging Digital Technologies Summit NASSCOM League of 10 I Emerge 50 Awards 2020 Public Health Innovative Startup Award in PHIC Conclave Gold award in the 5th edition of the IHW Council CSR Health Impact Awards 2021 in the CSR COVID Indigenous Response Project category AEGIS Graham bell awards 2020 Silver award in the 7th edition of the IHW Council CSR Digital Health Award IndiaCSR best healthcare initiative award for MillionICU Initiative Videos Dozee in News Republic World, June 25, 2024 - Economic Times HealthWorld, Oct 20, 2023 - Hindu Business Line, Nov 07, 2023 - To know more about life@dozee, .