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Clinical Trial Manager Ii (Client Base)

3+ years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Clinical Trial Manager II (Client Base)

Company: Syneos Health
Updated: April 17, 2025
Location: India-Asia Pacific – IND-Home-Based
Job ID: 25003156


Job Title: Clinical Trial Manager II

About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions organization built to accelerate customer success. With a Clinical Development model centered on patients and clients, we deliver streamlined, simplified services. We aim to be easier to work with and for, fostering innovation, collaboration, and outcomes-driven work. Our workforce spans 110 countries with 29,000 employees, united in their mission to change lives.

Why Join Us:

  • Career development opportunities and progression

  • Supportive leadership and peer recognition

  • Comprehensive rewards program

  • Commitment to diversity, inclusion, and authentic self-expression through our "Total Self" culture


Job Responsibilities:

  • Oversee site management, clinical monitoring, and central monitoring deliverables ensuring protocol/GCP/regulatory compliance and patient safety

  • Manage site interactions post-activation through closeout, including patient recruitment and investigator payments

  • Identify and mitigate risks related to protocol execution and clinical deliverables

  • Collaborate with functional leads across Study Start-Up, Patient Recruitment, and Data Management for handoffs and milestone achievement

  • Ensure systems (CTMS, EDC, TMF, ePRO, etc.) are effectively set up and maintained for clinical operations

  • Develop, implement, and maintain study-specific plans, templates, and tools (e.g., Clinical Monitoring Plan)

  • Coordinate protocol training for study teams and ensure compliance with SOPs and clinical guidelines

  • Lead and assess performance of CRAs and Central Monitors, ensuring quality and compliance

  • Review monitoring documentation to ensure accurate representation of trial conduct and compliance

  • Serve as escalation point for site communication, including conflict resolution and onsite visits when needed

  • Support inspection readiness activities and contribute to cross-functional coordination

  • Provide feedback on staff performance and development areas

  • Contribute to larger, more complex trials as assigned


Qualifications:

  • Experience:

    • Minimum 3 years of clinical project management experience

    • End-to-end project management from startup to closeout

    • India-specific project experience preferred

  • Education:

    • Bachelor’s degree or RN in a related field (or equivalent education/experience)

  • Skills and Knowledge:

    • Strong leadership and team alignment capabilities

    • Understanding of clinical trial financials and budget management

    • Knowledge of ICH-GCP and applicable regulatory requirements

    • Experience in clinical or central monitoring

    • Familiarity with risk-based monitoring strategies

    • Strong communication, presentation, and interpersonal skills

    • Proficient in conflict resolution and problem-solving

    • Good computer proficiency

    • Critical thinking and analytical skills to identify and resolve issues

    • Willingness to travel up to 20%


About Syneos Health in Numbers:

  • Partnered on 94% of FDA-approved novel drugs in the last 5 years

  • Involved in over 200 studies, across 73,000 sites and 675,000+ trial patients


Additional Information:
Duties are not exhaustive and may be amended at the company’s discretion. Equivalent qualifications may be considered. The company upholds all employment law compliance, including the ADA and EU Equality Directive, and is committed to reasonable accommodations where needed.