Clinical Trial Manager

2 weeks ago

Pune, Maharashtra, India Syneos Health Full time
Job Description

We are seeking a highly organized and experienced Clinical Trial 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.

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.
- Identify and resolve any issues or challenges that arise during the course of the study.
- Maintain accurate and comprehensive documentation of all study-related activities.

Skills Required

- 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.

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