Clinical Research Project Manager

3 days ago

Navi Mumbai, Maharashtra, India Cellcure Cancer Centre Full time

Job Title: Clinical Research Project Manager

Location: Vile Parle / Thane

Working Days: Monday to Saturday (6 days)

Experience: 510 years (Oncology / Clinical Research preferred)

Employment Type: Full-time

About the Role:

MOC Cancer Care & Research Centre is seeking an experienced Clinical Research Project Manager to oversee and manage clinical trials across multiple oncology phases (I–IV). The role involves end-to-end project management, regulatory coordination, team leadership, and ensuring full compliance with GCP and DCGI guidelines.

Key Responsibilities:

Clinical Trial Management

  • Oversee the conduct of Phase I–IV oncology clinical trials, ensuring adherence to study protocols, timelines, and quality standards.
  • Counsel patients for study participation and manage informed consent processes.
  • Submit study documents and obtain approvals from Ethics Committees and regulatory bodies.
  • Coordinate with sponsors and CROs for study start-up, monitoring, and close-out activities.
  • Manage trial budgets, agreements, and financial tracking related to research activities.

Team & Quality Oversight

  • Lead, train, and supervise clinical research coordinators and site staff.
  • Monitor trial records, ensure data accuracy, and perform internal quality control checks.
  • Report Serious Adverse Events (SAEs) to DCGI and Ethics Committees within required timelines.
  • Prepare and maintain essential trial documentation for EC review, audits, and regulatory inspections.

Regulatory Compliance & Governance

  • Ensure compliance with DCGI regulations, ICMR guidelines, and GCP standards.
  • Liaise with auditors and sponsors during monitoring visits and inspections.

Cellular Therapy & Research Support

  • Support advanced research programs including Gamma Delta T-cell and TCR therapy trials, overseeing patient selection, logistics, infusion, and post-procedure monitoring.
  • Collaborate with clinical teams to ensure safety, protocol adherence, and quality outcomes.

Process Development & SOP Management

  • Develop and implement Standard Operating Procedures (SOPs) for the Research Unit.
  • Establish streamlined workflows, quality control systems, and process improvements for clinical and cellular therapy research.

Qualifications & Skills:

  • Master's / Bachelor's degree in Life Sciences, Pharmacy, or related field (Postgraduate in Clinical Research preferred).
  • 5–10 years of experience in clinical research, preferably in oncology.
  • In-depth understanding of GCP, ICH, DCGI, and ethical research practices.
  • Strong leadership, documentation, and project management skills.
  • Excellent communication and coordination abilities with multidisciplinary teams and sponsors.

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