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Sr Clin Ops Specialist

0-2 years
Not Disclosed
10 Dec. 1, 2024
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

The Senior Clinical Operations Specialist position at Syneos Health is designed for an experienced professional in clinical research. This role supports the operational aspects of clinical trials by ensuring site management, coordinating activities, and assisting with regulatory compliance.


Position Overview

Location: Home-Based, India-Asia Pacific
Updated: November 6, 2024
Job ID: 24005946

The role involves performing tasks in line with Syneos Health’s Corporate and Clinical Operations policies, supporting site management, and ensuring compliance with study protocols. You will handle a variety of administrative and operational duties while supporting the smooth functioning of clinical trials.


Key Responsibilities

  1. Site Management and Compliance:

    • Serve as the Sponsor representative for assigned clinical sites, ensuring that sites follow study protocols, procedures, and regulatory requirements.
    • Assist Clinical Monitoring staff with site management activities and troubleshoot issues as they arise.
  2. Documentation and Communication:

    • Prepare, maintain, and organize project files, site manuals, and reference tools.
    • Track and manage clinical and regulatory documents, ensuring that all necessary materials are updated and properly handled.
    • Handle site requests and route correspondence appropriately.
  3. Tracking and Coordination:

    • Maintain clinical tracking information and input data into databases.
    • Coordinate the ordering, packaging, and shipping of site supplies and materials.
    • Assist with organizing and attending team meetings, preparing meeting minutes, and managing action items.
  4. Training and Issue Resolution:

    • Identify potential issues and proactively resolve them or escalate when necessary.
    • Provide training and mentorship to junior Clinical Operations Specialists.
  5. Regulatory Compliance and Knowledge:

    • Ensure that all activities comply with ICH/GCP and other relevant clinical research standards.

Qualifications

  • Education: Associate’s degree preferred, or equivalent work experience in clinical research or related fields.
  • Experience:
    • Experience in clinical research, pharma, biotech, or a related field.
    • Knowledge of medical terminology, clinical data, and ICH/GCP guidelines.
  • Skills:
    • Excellent organizational, communication, and interpersonal skills.
    • Strong attention to detail and ability to prioritize multiple tasks.
    • Ability to embrace new technologies and adapt to changing processes.

Why Syneos Health?

  • Culture:
    Syneos Health is committed to a Total Self culture, allowing employees to authentically be themselves while offering development and career progression opportunities.

  • Benefits:
    The company promotes a work-life balance and offers competitive benefits, training, and a peer recognition program.


Application Information

This position offers an exciting opportunity for professionals passionate about clinical trials and operational management. If you meet the qualifications and are ready to contribute to a dynamic and fast-paced environment, Syneos Health encourages you to apply.