Clinical Trial Manager II

6 days ago

Mumbai, India Syneos Health Full time

Job Responsibilities

  • minimum 2 Years of project management experience.
  • Should have global pharma experience.
  • Candidate from Mumbai location preferred.
  • Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed
  • Implement clinical research protocols and ensure 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, providing regular updates to stakeholders
  • Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress
  • Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates
  • Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment
  • Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions
  • Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability

Qualifications:

  • Bachelor's degree in a related field (e.g., life sciences, clinical research)
  • Minimum of 3 years of experience in clinical trial management or a related field
  • 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

Certifications:

  • Certified Clinical Research Professional (CCRP) or equivalent certification preferred

Necessary Skills:

  • Strong analytical and problem-solving skills
  • Attention to detail and accuracy
  • Ability to manage multiple projects and priorities simultaneously
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
  • Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

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