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    Senior Clinical Research Associate

    Syngene
    3-6 years
    Not Disclosed
    Bangalore
    10 Oct. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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: Senior Clinical Research Associate

    Job Location:

    Bangalore

    Experience:

    3 - 6 Years

    Department:

    Clinical Operations

    About Syngene:

    Incorporated in 1993, Syngene International Ltd. is an innovation-focused global organization providing integrated scientific services across the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. Our clientele includes leading companies such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Our passionate team of 4,240 scientists collaborates with clients worldwide to solve scientific challenges, improve R&D productivity, accelerate time to market, and reduce innovation costs.

    Job Description:

    Role: Senior Clinical Research Associate

    Key Responsibilities:

    • Conduct site selection, initiation, monitoring, and close-out visits in compliance with the contracted scope of work, Standard Operating Procedures, and Good Clinical Practice (GCP) Guidelines and Regulations.
    • Manage assigned protocols, sites, and therapeutic areas effectively.
    • Complete all necessary training, including Standard Operating Procedures, therapeutic area, protocol training, and any other relevant training required for the role.
    • Provide protocol and study training to assigned sites and maintain regular communication to manage project expectations and activities.
    • Ensure the quality and integrity of studies conducted at the site level in accordance with protocols and applicable regulations. Investigate quality issues and collaborate with the Clinical Project Manager for resolution and implementation of Corrective Action and Preventive Action (CAPA).
    • Monitor the progress and performance of assigned study sites, including tracking regulatory and Ethics Committee submissions and approvals, subject recruitment, case report form (CRF) completion and submission, and data query generation and resolution.
    • Maintain documentation regarding site management, monitoring visit findings, and action plans, including regular visit reports and follow-up letters.
    • Assist the Clinical Project Manager with the design of study tools, documents, and processes.
    • Submit timesheets promptly for project-specific and other tasks.
    • If assigned as a Lead Clinical Research Associate, responsibilities may include supporting the Clinical Project Manager in project coordination and delegating project-level Clinical Project Manager responsibilities.

    Educational Qualification:

    M.Sc / M.Pharm / Pharm D / BAMS / BDS / MDS / BHMS or any life science degree.

    Experience:

    3 - 9 Years

    Behavioral Skills:

    • Strong communication skills and a collaborative team player.
    • Ability to thrive in a dynamic and ambiguous environment.
    • Capable of meeting tight deadlines and prioritizing workloads.
    • Creative problem-solver with a focus on results.
    • Detail-oriented and focused on job responsibilities.

    Equal Opportunity Employer:

    Syngene is committed to providing equal employment opportunities (EEO) to all individuals regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity, genetic information, marital status, or any other characteristic protected by applicable law. Reasonable accommodations will be provided for qualified individuals with disabilities.

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