Job Title: Clinical Trial Manager
Location: Navi Mumbai, India
About BayNine Ventures
BayNine Ventures is a dynamic and innovative research organization dedicated to advancing healthcare solutions through rigorous scientific investigation. We are committed to improving the lives of individuals and families affected by autism through cutting-edge research and development. We are currently seeking a highly motivated and experienced Clinical Trial Manager to join our team and play a pivotal role in a groundbreaking global research project focused on a novel homeopathy-based autism treatment.
Summary:
We are seeking an experienced Clinical Trial Manager to spearhead the execution of a global clinical trial evaluating a novel homeopathy-based autism treatment. This is a unique opportunity to contribute to a high-impact research project with the potential to transform autism care. The ideal candidate will have a strong background in multi-country clinical trial management, CRO oversight, and regulatory submissions across India, the EU, and Canada. If you are a passionate and detail-oriented professional with a proven track record of success in clinical research, we encourage you to apply.
Job Description:
As a Clinical Trial Manager at BayNine Ventures, you will be responsible for the end-to-end management and execution of a multi-national clinical trial focused on a promising new autism treatment. This role demands a highly organized, detail-oriented, and proactive individual with a strong understanding of clinical trial methodologies, regulatory requirements, and CRO management. You will be instrumental in ensuring the successful conduct of the trial, adherence to ethical guidelines, and the integrity of the data collected.
Responsibilities:
- Lead and manage all aspects of clinical trial execution, from study start-up to close-out, in accordance with global standards, including ICH-GCP and NDCT Rules.
- Serve as the primary point of contact for CROs, vendors, and other external partners involved in the international study. This includes overseeing their activities, managing contracts, and ensuring adherence to study protocols and timelines.
- Develop and maintain comprehensive clinical trial documentation, including study protocols, informed consent forms, investigator brochures, and clinical study reports.
- Oversee data management activities, ensuring data quality, integrity, and compliance with regulatory requirements.
- Conduct regular site monitoring visits to ensure compliance with study protocols, regulatory requirements, and ethical guidelines.
- Manage and coordinate clinical trial audits, both internal and external, and implement corrective actions as needed.
- Collaborate closely with cross-functional teams, including R&D, regulatory affairs, medical affairs, and data science, to ensure seamless execution of the clinical trial.
- Ensure the ethical conduct of the clinical trial, adherence to safety reporting requirements, and compliance with standard operating procedures (SOPs) and quality benchmarks.
- Proactively identify and mitigate potential risks to the clinical trial, and develop contingency plans to address unforeseen challenges.
- Contribute to the preparation of regulatory submissions, including INDs, CTAs, and marketing authorization applications, across India, the EU, and Canada.
- Maintain a thorough understanding of the scientific literature and current trends in autism research.
Qualifications:
- Bachelor’s or Master’s degree in Biotechnology, Life Sciences, or a related field. A PhD or MD is an advantage but not mandatory.
- Minimum of 5-8 years of experience in managing multicentric or global clinical trials.
- Proven experience with CRO/vendor oversight, including selection, management, and performance monitoring.
- In-depth knowledge of regulatory requirements for clinical trials in India, the EU, and Canada.
- Experience with regulatory submissions (e.g., INDs, CTAs) is highly desirable.
- Mandatory ICH-GCP certification.
- Excellent communication, interpersonal, and problem-solving skills.
- Strong organizational skills and attention to detail.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS).
Benefits:
- Opportunity to contribute to a mission-driven research program focused on improving the lives of individuals with autism.
- Exposure to global multi-country clinical studies and cutting-edge research methodologies.
- Leadership pathway within a rapidly growing R&D ecosystem.
- Full-time onsite role in Navi Mumbai, India, with potential for travel opportunities.
- Competitive salary and benefits package.
How to Apply:
If you meet the qualifications and are passionate about making a difference in the lives of individuals with autism, we encourage you to apply. Please submit your updated resume to [email protected].