Clinical Research Manager

Job Title: Clinical Research Manager

Company: Baynine Ventures LLP

Location: Navi Mumbai + Travel

Employment Type: Full-time

Experience Required: 5–10 years

Role Overview:

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

Job Type: Full-time

Pay: ₹60, ₹95,000.00 per month

Benefits:

• Provident Fund

Work Location: In person