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    Cda Iii

    Syneos Health
    4-6 years
    Not Disclosed
    Remote
    10 Dec. 30, 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

    Clinical Data Associate III
    Updated: December 2, 2024
    Location: India-Asia Pacific - IND-Home-Based, India
    Job ID: 24006517

    Job Description

    Clinical Data Associate III

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

    Our Clinical Development model places the customer and the patient at the center of everything we do. We are continuously innovating to simplify and streamline our processes, not only making Syneos Health easier to work with but also creating a workplace that’s even more rewarding.

    Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll work alongside passionate problem solvers, collaborating as a team to help our customers achieve their goals. We are agile, driven, and passionate about accelerating the delivery of therapies to change lives.

    Discover why our 29,000 employees across 110 countries already know:
    WORK HERE MATTERS EVERYWHERE

    Why Syneos Health

    At Syneos Health, we’re committed to developing our people through career progression, technical training, peer recognition, and a total rewards program. Our Total Self culture celebrates authenticity, where everyone can bring their true selves to work. Diversity of thought, background, and perspective creates an environment where everyone belongs.

    Job Responsibilities

    • Maintain awareness of contract elements and scope of work for assigned projects, providing status updates to the Project Manager and/or Biometrics Project Manager as necessary.
    • Review and adhere to study-specific Clinical Data Management Plans.
    • Create and enter test data for User Acceptance Testing (UAT) and perform UAT for data entry screens, edit checks, data review listings, and Targeted Source Data Verification (SDV) configurations.
    • Enter lab normal ranges and complete CDMS-specific access forms/spreadsheets.
    • Perform discrepancy reviews, validate data entered into the clinical database, apply corrections where necessary, and resolve queries in alignment with Data Validation Specifications (DVS).
    • For paper studies, review Data Clarification Forms (DCFs) and ensure CRF databases are updated accordingly. Perform internal QC checks and manage the CRF database.
    • For EDC studies, conduct internal QC checks, create electronic storage media, and participate in audits as required.
    • Maintain proficiency in data management systems through regular training (CDA Knowledge College).
    • Oversee the work of other Clinical Data Associates (CDAs) assigned to the project, ensuring project timelines and quality standards are met.
    • Provide project-specific training to other CDAs and ensure the consistency of data from external sources (e.g., central lab, PK data, IRT).
    • Conduct QC of Data Dictionaries for code lists and support post-migration testing.
    • Participate in meetings with customers, distribute relevant information, and maintain accurate meeting minutes.
    • Review and provide input into Data Validation Specifications and database design specifications.
    • Support Project Data Managers (PDM) by updating documents, creating reports, and providing input on data management activities.
    • Understand the coding process and the importance of interim data cuts and dry runs.

    Qualifications

    What We’re Looking For:

    • BA/BS degree in Biological Sciences, Healthcare, or related field.
    • 4 to 6 years of experience in clinical data management activities. Exposure to the Closeout Phase (DB Lock, Freezing & Locking) is a value add.
    • Experience with UAT, migrations, and DM documentation; oncology trial experience is preferred.
    • Hands-on experience with EDC platforms like Veeva/RAVE/INFORM is preferred.
    • Familiarity with relational database management systems, Oracle Clinical, Rave, or Inform is preferred.
    • Strong knowledge of clinical data, ICH/GCP, and medical terminology.
    • Proficiency in Microsoft Office Suite (Word, Excel) and strong keyboard skills.
    • Excellent communication, interpersonal, and organizational skills with the ability to manage tasks under tight deadlines.
    • Ability to multitask, adapt to changes, and work independently or in a team.
    • Ability to travel up to 25%.

    Get to Know Syneos Health

    Over the past 5 years, we have worked with 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites and 675,000+ trial patients.

    No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health and the difference we’re making in the biopharmaceutical industry.

    Additional Information

    The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign additional tasks or responsibilities as necessary. Equivalent experience, skills, and/or education will be considered. All job descriptions comply with applicable legislation and ensure equal opportunities in recruitment and employment practices.

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