Director of Clinical Operations

8 hours ago

Anantapur, Andhra Pradesh, India beBeeClinicalResearch Full time ₹ 1,80,00,000 - ₹ 2,10,00,000
Job Overview

The Senior Clinical Research Manager will oversee the planning, execution, and management of clinical trials and research studies. This role requires strategic leadership and collaboration with cross-functional teams to ensure timely completion and regulatory compliance.

This individual will supervise research staff, develop training programs, and provide ongoing professional development to enhance team performance.

Key Responsibilities:Clinical Trial Management
  • Project Planning and Execution
  • Coordinate and oversee the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
  • Regulatory Compliance
  • Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
  • Team Leadership
  • Lead and mentor clinical research staff, ensuring they are trained and performing effectively.
Regulatory Affairs and Compliance
  • Documentation and Submission
  • Oversee the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.
  • Compliance Monitoring
  • Monitor compliance with federal, state, and local regulations, as well as company policies.
Study Design and Protocol Development
  • Protocol Development
  • Work with scientific and medical teams to develop clinical trial protocols.
  • Feasibility Evaluation
  • Evaluate feasibility and risk of proposed studies.
Data Management and Reporting
  • Data Quality Assurance
  • Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.
  • Progress Reporting
  • Prepare and present progress reports to senior leadership and stakeholders.
Collaboration and Communication
  • Stakeholder Engagement
  • Foster communication between internal teams, external partners, and key stakeholders.
  • Issue Resolution
  • Resolve any issues related to clinical trial execution and provide solutions.
Qualifications

A bachelor's degree in Life Sciences, Clinical Research, or a related field; 8-18 years of experience in clinical research; strong project management, leadership, and organizational skills; excellent communication and interpersonal skills; proficiency in clinical research software and data management systems; strong problem-solving and decision-making abilities.

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