Senior Clinical Trials Coordinator

3 days ago

Pune, Maharashtra, India beBeeClinical Full time
Clinical Research Project Manager Position

We are seeking a highly organized and experienced Clinical Research Project Manager to oversee the development, coordination, and implementation of Phase 1 clinical research studies. This role is crucial for meticulously planning logistics, tracking study progress against milestones, and ensuring strict compliance with all regulatory requirements.

The successful candidate will have in-depth knowledge of clinical research processes and regulations, strong project management and organizational skills, excellent communication and interpersonal skills, ability to work independently and as part of a team, proficiency in using clinical trial management software and tools, and strong analytical and problem-solving skills.

Roles and Responsibilities:
  • Develop and coordinate Phase 1 clinical research studies, ensuring meticulous planning and execution.
  • Implement clinical research protocols and ensure strict compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines.
  • Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination.
  • Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation.
  • Track study progress and ensure alignment with project milestones, client deliverables, and budget.
  • Prepare and present study reports and updates to stakeholders, including detailed analysis of study data.
  • Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes.
  • Provide guidance and support to lower-level professionals and team members.
  • Maintain accurate and comprehensive documentation of all study-related activities.
Required Skills and Qualifications:
  • Bachelor's degree in a related field (e.g., life sciences, clinical research).
  • In-depth knowledge of clinical research processes and regulations.
  • Strong project management and organizational skills.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Proficiency in using clinical trial management software and tools.
  • Strong analytical and problem-solving skills.
  • Attention to detail and accuracy.
  • Ability to manage multiple projects and priorities simultaneously.
  • Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
  • A Certified Clinical Research Professional (CCRP) or equivalent certification is preferred.
Benefits:

This role offers a competitive salary, opportunities for professional growth and development, and a dynamic work environment that values teamwork and collaboration.

Other Information:

Please note that this position requires a background check and may be subject to other screening processes.

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