Job Description

Clinical Research Manager Location-New Delhi Exp-9-18yrs About the Job

• Plans, develops, and manages the clinical studies and associated administrative activities of a large, complex medical research study or group of studies.
• Develops budgets, operating procedures, and coordinates the procurement and installation of required facilities, equipment, and materials.
• Provides direct patient care services as appropriate, and oversees the recruitment, care, and treatment of research subjects.
• Assesses operational, financial, and materials requirements for the study and prepares operating budgets; plans and coordinates the procurement of required clinical facilities, equipment, and supplies.
• Plans and carries out programs for the recruitment, screening, enrolment, and retention of clinical research subjects.
• Establishes appropriate data collection systems and procedures, according to pre-established research protocol; coordinates and monitors the collection, processing, and recording of clinical data, as required by established study protocol.
• Supervise CRAs in in-house and on-site monitoring, filing and clinical study administration
• Monitoring the trial\xe2\x80\x99s budget, confirming that the work is staying within approved parameter
• Provide efficient updates on trial progress to the Clinical Program Director (CPD), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
• Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operating procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Chair CTT working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Remaining on schedule, ensuring the timely completion of clinical study

Job Type: Full-time Salary: 9500,000.00 - 91,300,000.00 per year Benefits:

• Cell phone reimbursement
• Commuter assistance
• Flexible schedule
• Health insurance
• Internet reimbursement
• Provident Fund

Schedule:

• Morning shift

Ability to commute/relocate:

• New Delhi, Delhi: Reliably commute or planning to relocate before starting work (Required)

Experience:

• total work: 1 year (Preferred)

Speak with the employer
+91-XXXXXXXXXX