Instagram
youtube
Facebook

Clinical Trial Manager I

3+ years
Not Disclosed
10 Nov. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Trial Manager I

Updated: October 16, 2025
Location: India – Client-Based
Job ID: 25102351
Company: Syneos Health®


About Syneos Health

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization that partners with clients to accelerate success across clinical development, medical affairs, and commercial functions.

With a footprint spanning 110 countries and over 29,000 employees, Syneos Health has partnered with:

  • 94% of all FDA-approved novel drugs in the past 5 years

  • 95% of EMA-authorized products

  • More than 200 studies across 73,000 sites and 675,000+ trial patients

Core Philosophy: Work Here Matters Everywhere — uniting diverse teams worldwide through a “Total Self” culture of authenticity, inclusion, and growth.


Position Overview

The Clinical Trial Manager I (CTM I) is responsible for overseeing, coordinating, and implementing Phase 1 clinical research studies.
This includes planning logistics, managing study operations, ensuring adherence to regulatory standards (such as GCP), and facilitating communication among investigators, clients, and internal teams.

This role demands strong project management, leadership, and organizational skills to ensure clinical trials are executed efficiently and compliantly.


Experience & Location Requirements

  • Minimum Experience: 2 years in project management

  • Global pharmaceutical experience required

  • Preferred Location: Mumbai, India


Key Responsibilities

  • Study Management:

    • Oversee and coordinate Phase 1 clinical research studies

    • Ensure all study activities are executed per protocol, GCP, and regulatory standards

  • Planning & Execution:

    • Develop, implement, and monitor clinical research protocols

    • Manage timelines, budgets, and resources effectively

  • Collaboration & Communication:

    • Serve as liaison between principal investigators, research subjects, client teams, and clinical operations

    • Facilitate effective cross-functional communication

  • Regulatory Compliance:

    • Ensure compliance with global and regional regulations

    • Stay updated on changes in regulatory and GCP guidelines

  • Documentation & Reporting:

    • Maintain comprehensive study documentation and reports

    • Track study progress against project milestones and deliverables

    • Prepare presentations and updates for stakeholders

  • Leadership & Support:

    • Guide and support junior professionals and team members

    • Foster collaboration and problem-solving across teams

  • Issue Resolution:

    • Identify and resolve study-related issues promptly

    • Implement corrective actions and preventive measures


Qualifications

  • Education: Bachelor’s degree in Life Sciences, Clinical Research, or a related field

  • Experience: Minimum 3 years in clinical trial management or equivalent field experience

  • Technical Knowledge:

    • Strong understanding of clinical research processes, ICH-GCP, and regulatory frameworks

    • Proficiency in clinical trial management systems (CTMS) and related tools

  • Project Skills:

    • Strong organizational and time management abilities

    • Excellent written and verbal communication

    • Effective stakeholder management


Certifications

  • Preferred: Certified Clinical Research Professional (CCRP) or equivalent certification


Core Skills

  • Analytical and critical thinking

  • Attention to detail and accuracy

  • Problem-solving and decision-making

  • Ability to handle multiple projects simultaneously

  • Strong interpersonal and leadership skills

  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)


Core Focus Areas

  • Planning, coordinating, and overseeing Phase 1 clinical trials

  • Collaborating with investigators and stakeholders across global operations

  • Managing trial logistics, progress tracking, and budget alignment

  • Ensuring regulatory compliance and GCP adherence

  • Supporting design and implementation of clinical processes and policies


Impact & Contribution

Roles within the Clinical Trial Management (P22 level) directly influence the success and quality of clinical studies by ensuring operational excellence.
They contribute to advancing medical research, improving process efficiency, and supporting the development of new therapeutic solutions through disciplined project leadership and compliance oversight.


Why Join Syneos Health

  • Career growth through continuous learning and internal mobility

  • Supportive and transparent management

  • Recognition and rewards programs

  • Inclusive, authentic workplace culture fostering diversity of thought

  • Global exposure and meaningful impact on healthcare innovation


Additional Information

  • Responsibilities and tasks may evolve as needed

  • Equivalent qualifications or experience may be considered

  • Syneos Health complies with the Americans with Disabilities Act (ADA) and EU Equality Directive, ensuring equal opportunities and reasonable accommodations


Summary

The Clinical Trial Manager I ensures high-quality management of early-phase clinical trials through precise planning, regulatory adherence, and strong leadership. The role demands cross-functional collaboration and strategic execution to advance global clinical research.

Website: www.syneoshealth.com