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    Cda I (Data Management)

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    10 March 3, 2025
    Job Description
    Job Type: Full Time Education: BA/BS 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 I

    Updated: February 26, 2025
    Location: India-Asia Pacific - IND-Home-Based
    Job ID: 25001974

    Description:
    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 to address modern market realities.

    Our Clinical Development model brings the customer and the patient to the center of everything we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for.

    Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

    Why Syneos Health:

    • We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards programs.
    • We are committed to our Total Self culture, where you can authentically be yourself. Our Total Self culture unites us globally, and we are dedicated to taking care of our people.
    • We are continuously building the company we all want to work for and our customers want to work with by bringing together diverse thoughts, backgrounds, cultures, and perspectives.

    Job Responsibilities:

    • Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
    • Reviews and adheres to study-specific Clinical Data Management Plans.
    • Receives and enters lab normal ranges.
    • Completes and submits Clinical Database Management System (CDMS)-specific access forms.
    • Performs review of discrepancy (edit check) output and validation listings based on entered clinical database data.
    • Queries or applies self-evident corrections per the Data Validation Specification (DVS) and/or Data Management Plan (DMP).
    • For paper studies, reviews Data Clarification Forms (DCFs) answered by sites and edits Case Report Forms (CRFs) and database accordingly.
    • Ensures all CRFs and DCFs received are returned for filing per Data Tracking Guidelines.
    • Serves as back-up to data entry, pre-reviewing CRFs and performing QC review for paper and hybrid studies.
    • Performs DM quality review and internal QC checks per applicable Electronic Data Capture (EDC) systems.
    • Tracks project progress and issues periodic status reports.
    • Completes all activities necessary for finalizing and transferring clinical database and related project documents.
    • Identifies the achievement of milestones per scheduled plans.
    • Creates electronic storage media per standard operating procedures (SOPs).
    • Participates in internal meetings and internal/external audits.
    • Files documentation in the Data Management Study File (DMSF).
    • Assists with study archival.
    • Maintains proficiency in DM systems and processes through training courses.
    • Understands the coding process and interim, dry run, data cut procedures.

    Qualifications:

    • BA/BS degree in biological sciences or related fields.
    • Experience with DM practices and relational database management software preferred.
    • Knowledge of Oracle Clinical, Rave, or Inform systems preferred.
    • Understanding of clinical data, ICH/Good Clinical Practices, and medical terminology preferred.
    • Proficiency in MS Windows, MS Word, Excel, and email applications.
    • Excellent speed and accuracy in keyboard skills.
    • Work experience in clinical research, drug development, data management, or healthcare preferred.
    • Strong communication, presentation, and interpersonal skills.
    • Good organizational, planning, and time management skills.
    • Ability to multitask under tight deadlines with attention to detail.
    • Ability to work independently and as part of a multi-disciplinary team.
    • Responsible for compliance with applicable Corporate Business Practices, SOPs, and Working Instructions.
    • Minimal travel may be required (up to 25%).

    Get to Know Syneos Health:
    Over the past five years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

    No matter what your role is, you’ll take initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

    Additional Information:

    • Tasks, duties, and responsibilities as listed are not exhaustive.
    • The company may assign other tasks at its sole discretion with no prior notice.
    • Equivalent experience, skills, and education will be considered.
    • This job description does not create an employment contract.
    • The company complies with all applicable employment laws, including the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations when appropriate.

     

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