Clinical Trial Manager

2 weeks ago

Pune, Maharashtra, India Syneos Health Full time
Job Description

Job Responsibilities

- Develop and coordinate Phase 1 clinical research studies, ensuring detailed planning and flawless execution.
- Implement clinical research protocols while ensuring compliance with Good Clinical Practice (GCP) and other regulatory requirements.
- Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to ensure smooth study execution.
- Plan and manage logistics, scheduling, budgeting, and resource allocation for clinical trials.
- Track study progress against milestones, deliverables, and budgets, and provide regular updates to stakeholders.
- Prepare and present study reports, data analyses, and progress updates to clients and internal teams.
- Ensure adherence to global and regional regulations while staying updated with any regulatory changes.
- Provide guidance and mentorship to junior team members, fostering collaboration.
- Identify and resolve issues or risks during the study, ensuring timely corrective actions.
- Maintain comprehensive documentation of all study-related activities.

Qualifications

- Bachelor's degree in Life Sciences, Clinical Research, or a related field.
- 3+ years of experience in clinical trial management or related field.
- Strong knowledge of clinical research processes, GCP, and regulatory requirements.
- Proven project management and organizational skills.
- Excellent communication and interpersonal skills with ability to work independently and in teams.
- Proficiency with clinical trial management systems (CTMS) and tools.

Preferred Certifications

- Certified Clinical Research Professional (CCRP) or equivalent preferred.

Skills Required

- Strong analytical and problem-solving abilities.
- High attention to detail and accuracy.
- Ability to manage multiple projects and priorities simultaneously.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

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