Senior Clinical Operations Director

2 days ago

Agra, Uttar Pradesh, India beBeeClinicalResearch Full time ₹ 1,00,00,000 - ₹ 2,00,00,000

Job Summary:

The Senior Clinical Research Manager will lead and oversee clinical trials and research studies, ensuring timely completion within regulatory standards.

Key Responsibilities:

  1. Clinical Trial Management:
  • Develop and execute clinical research projects from start to finish.
  • Coordinate the execution of clinical trials, adhering to protocols, timelines, and budget requirements.
  • Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards.
  • Oversee recruitment, enrollment, and monitoring of clinical trial subjects.
  • Manage relationships with external partners, investigators, and vendors.
Team Leadership:
  • Lead and mentor research staff, ensuring they are trained and performing effectively.
  • Assign tasks and responsibilities to team members based on project needs.
  • Develop training programs and provide ongoing professional development for research teams.
Regulatory Compliance:
  • Oversight preparation and submission of regulatory documentation, including IRB applications and clinical trial applications.
  • Monitor compliance with federal, state, and local regulations, as well as company policies.
  • Ensure timely reporting of adverse events and ensure the study meets ethical and regulatory standards.
Study Design & Protocol Development:
  • Work with scientific and medical teams to develop clinical trial protocols.
  • Ensure protocols meet study objectives, regulatory standards, and ethical guidelines.
  • Evaluate feasibility and risk of proposed studies.
Data Management and Reporting:
  • Ensure data collection, monitoring, and analysis are conducted efficiently and accurately.
  • Review and analyze clinical trial data to ensure quality and integrity.
  • Prepare and present progress reports to senior leadership and stakeholders.
Budget and Resource Management:
  • Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.
  • Oversee resource allocation, including personnel, equipment, and materials.
Collaboration and Communication:
  • Foster communication between internal teams, external partners, and key stakeholders.
  • Collaborate with research coordinators, data managers, and other departments to ensure effective study execution.
  • Resolve any issues related to clinical trial execution and provide solutions.
Continuous Improvement:
  • Identify areas for process improvement in clinical trial execution and management.
  • Implement best practices to optimize research efficiency and compliance.

Required Skills and Qualifications:

  • Bachelor's degree in Life Sciences, Clinical Research, or a related field (Master's or higher preferred).
  • 8-18 years of experience in clinical research, with at least 2-3 years in a managerial or supervisory role.
  • In-depth knowledge of clinical trial management, regulatory requirements, and GCP.
  • Strong project management, leadership, and organizational skills.
  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
  • Proficiency in clinical research software and data management systems.
  • Strong problem-solving and decision-making abilities.
  • Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred (or equivalent).

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