We are seeking a Global Clinical Research Lead to drive and manage end-to-end execution of our multi-country clinical research program focused on a pioneering homeopathy-based treatment for autism. The role requires strong leadership in CRO/vendor management, regulatory alignment (India and international), and strategic execution across prospective trials in India , EU and Canada.
This role reports directly to the Founder/Chief Scientific Officer and will serve as the owner of all clinical operations, ensuring delivery with scientific integrity, budget discipline, and regulatory compliance.
Key Responsibilities
Strategic Oversight & Planning
Lead the full clinical trial lifecycle from feasibility to CSR submission across India, EU, and Canada.
Align clinical strategy with product development and regulatory approval timelines.
Co-develop protocol design, inclusion/exclusion criteria, endpoints, and outcome assessment metrics.
CRO & Vendor Management
Select and manage CROs for India and international studies.
Oversee contracts, Scope of work, deliverables, and milestone-based payments.
Maintain rigorous control over cost, timelines, scope creep, and quality metrics.
Regulatory Leadership (India + Global)
Oversee regulatory submissions to CDSCO, CTRI, and local IECs.
Have an understanding of international regulatory requirements for EMA/Health Canada processes.
Ensure adherence to ICH-GCP, NDCT Rules 2019, and international trial ethics.
Data, Documentation & Scientific Integrity
Collaborate with bioinformatics, biostatistics, and medical writing experts.
Review and approve SAPs, CRFs, CSRs, and other scientific reports.
Maintain end-to-end visibility into clinical data quality and signal detection.
Trial Execution & Operational Control
Maintain oversight of site performance (recruitment, protocol adherence).
Coordinate with internal teams for data management, safety, and reporting.
Monitor risk logs, protocol deviations, and site readiness (directly or via CRA/CRO).
Stakeholder Management & Communication
Act as the single point of contact between CROs, investigators, consultants, and internal leadership.
Coordinate with cross-functional teams: R&D, product, regulatory, and analytics.
Provide monthly dashboards and executive updates.
Qualifications
Bachelor's or Master's in
Biotechnology/Bioinformatics
, Life Sciences, or MBBS; PhD/MD preferred.
5-10 years of experience in clinical research, with at least 3-5 years in a global or multicentric project management role.
Prior experience with integrative medicine, or special population studies is preferred.
Demonstrated track record of managing
CROs
and executing trials in India and at least one other regulatory geography (EU/Canada ideal).
Strong understanding of
ICH-GCP, NDCT
Rules, and global ethical standards.
Excellent communication, negotiation, and stakeholder alignment skills.
GCP
Certification is mandatory.
Preferred Traits
Self-driven, accountable, and detail-oriented with a problem-solving mindset.
Exposure to pediatric, neurodevelopmental, or behavioral health trials is a strong plus.
Familiarity with digital trial tools like EDC, eTMF, CTMS (e.g., Medidata, OpenClinica, Veeva Vault).
Willingness to travel (10-20%) for site visits, investigator meetings, or regulatory follow-ups.
What We Offer
A mission-driven opportunity to shape real-world outcomes for autism care.
Ownership and autonomy in building a globally credible clinical development program.
Collaborative, cross-disciplinary work environment.
Hybrid work model and long-term leadership growth
If interested share your updated CV via
litishia.cherian@baynineventures.com
Job Type: Full-time
Pay: ?60,000.00 - ?95,000.00 per month
Benefits:
Provident Fund
Work Location: In person
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