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    Sr. Clinical Research Associate

    Syngene
    3-9 years
    Not Disclosed
    Bangalore
    10 Jan. 30, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Senior Clinical Research Associate

    Job Location: Bangalore
    Department: Clinical Operations
    Experience Required: 3 - 9 years
    Education: M.Sc / M.Pharm / Pharm D / BAMS / BDS / MDS / BHMS / Any Life Science

    About Syngene

    Syngene International Ltd., established in 1993, is a global contract research, development, and manufacturing organization (CRDMO) providing integrated scientific solutions to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries.

    Syngene partners with leading global companies, including Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife, leveraging the expertise of 4,240+ scientists to enhance R&D productivity, accelerate time-to-market, and reduce innovation costs.

    Job Purpose

    The Senior Clinical Research Associate (Sr. CRA) will be responsible for the site selection, initiation, monitoring, and close-out visits for clinical studies in compliance with Good Clinical Practice (GCP) guidelines and regulatory standards. The role requires effective site management, adherence to study protocols, and collaboration with the Clinical Project Manager (CPM) to ensure the quality and integrity of clinical trials.

    Key Responsibilities

    Clinical Site Management & Monitoring

    • Conduct site selection, initiation, monitoring, and close-out visits in compliance with GCP guidelines, SOPs, and regulatory requirements.
    • Manage assigned protocols, study sites, and therapeutic areas, ensuring adherence to project timelines and quality standards.
    • Establish regular communication with sites to manage study expectations, monitor progress, and resolve issues.
    • Oversee site-level activities, including:
      • Regulatory and Ethics Committee approvals
      • Subject recruitment tracking
      • Case Report Form (CRF) completion and submission
      • Data query resolution

    Compliance & Quality Assurance

    • Ensure quality and integrity of clinical trials conducted at study sites.
    • Identify and address any quality issues in coordination with the Clinical Project Manager.
    • Implement Corrective and Preventive Actions (CAPA) as needed to maintain compliance.
    • Maintain accurate and timely documentation of site management activities, visit reports, and follow-up actions.

    Training & Documentation

    • Complete mandatory training, including:
      • Standard Operating Procedures (SOPs)
      • Therapeutic area protocols
      • Regulatory compliance training
    • Conduct study training sessions for site personnel and assist in designing study tools and documents.

    Project Management Support

    • Assist the Clinical Project Manager (CPM) with study documentation and process improvements.
    • Submit timely project-specific timesheets.
    • When assigned as a Lead Clinical Research Associate (Lead CRA):
      • Support the CPM in coordinating project teams.
      • Take on delegated CPM responsibilities and project-level tasks.

    Skills & Competencies

    Technical Skills

    • Strong knowledge of GCP guidelines and regulatory requirements for clinical trials.
    • Expertise in clinical site monitoring and management.
    • Ability to handle regulatory submissions and Ethics Committee approvals.
    • Experience in data collection, query resolution, and documentation.

    Behavioral Skills

    • Excellent communication skills for collaboration with internal and external stakeholders.
    • Strong organizational and time management skills to handle multiple tasks efficiently.
    • Ability to work in a fast-paced environment and meet tight deadlines.
    • Proactive problem-solving and critical thinking skills.
    • Team-oriented mindset, with the ability to work independently when required.

    Syngene Values

    All employees are expected to align with Syngene’s core values:

    • Excellence
    • Integrity
    • Professionalism

    Equal Opportunity Employer

    Syngene is committed to providing equal employment opportunities (EEO) to all individuals, regardless of age, gender, nationality, race, religion, disability, or other protected characteristics. The company ensures a fair and inclusive workplace and offers reasonable accommodations for qualified individuals with disabilities.

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