Clinical Data Associate I (Inform)

1-2 years

Not Disclosed

India

10 April 3, 2025

Job Description

Job Type: Remote Education: BS/BA Degree preferred in Biological sciences/Health care/Clinical Research. 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 (Inform EDC)

Company: Syneos Health
Location: Global

About Syneos Health

Syneos Health is a leading biopharmaceutical solutions organization, integrating clinical, medical affairs, and commercial insights to drive success in drug development. With 29,000 employees across 110 countries, we simplify clinical development to accelerate the delivery of life-changing therapies.

Join us—because work here matters everywhere.

Job Responsibilities

Clinical Data Management & Review

Maintain awareness of contract and scope of work for assigned projects.
Review and adhere to Clinical Data Management Plans.
Receive and enter lab normal ranges.
Complete and submit Clinical Database Management System (CDMS) access forms.
Perform discrepancy management and data validation based on clinical database entries.
Query and apply self-evident corrections per Data Validation Specification (DVS) and Data Management Plan (DMP).

Data Entry & Quality Control (QC)

Perform internal QC checks via listing output from the database against Case Report Forms (CRFs) and Data Clarification Forms (DCFs).
Ensure proper filing of CRFs and DCFs as per Data Tracking Guidelines.
Serve as backup for data entry in paper and hybrid studies.
Conduct pre-review and QC review of CRFs in image-based systems.
Perform quality review and internal checks in Electronic Data Capture (EDC) studies.

Study Tracking & Finalization

Track project progress and issue periodic status reports.
Participate in database finalization and sponsor transfers.
Assist in milestone achievement and project scheduling.
Create electronic storage media for EDC studies.
Participate in internal audits and meetings.
File documentation in the Data Management Study File (DMSF) and assist with study archival.

Additional Responsibilities

Maintain proficiency in DM systems through ongoing training.
Understand coding processes and interim data reviews.
Ensure compliance with corporate business practices, SOPs, and regulatory guidelines.
Travel up to 25% as required.

Required Qualifications

Education: BA/BS in biological sciences, health care, or related disciplines.
Experience:
- 1-2 years of experience in clinical data management (CDM).
- Knowledge of CDM practices, relational database management, and medical terminology.
- Preferred: Experience with Inform EDC systems.
Technical Skills:
- Strong knowledge of ICH-GCP, clinical data, and discrepancy management.
- Experience in SAE, PK/PD, IVRS, lab data cleaning, and manual data review.
- Proficiency in MS Windows, Word, Excel, and email applications.
Soft Skills:
- Excellent communication, presentation, and organizational skills.
- Ability to multi-task under tight deadlines while ensuring accuracy.
- Ability to work independently and within a multi-disciplinary team.

Why Join Syneos Health?

Worked with 94% of all Novel FDA-Approved Drugs in the past 5 years.
Collaborated on 95% of EMA-Authorized Products and 200+ studies across 73,000 sites.
Competitive career development, mentorship, and rewards program.
Be part of a diverse, inclusive, and innovative workplace.

Join Us

We encourage applicants from diverse backgrounds and industries. If your experience doesn’t align perfectly, apply anyway—your skills may be transferable.

Join our Talent Network to stay updated on career opportunities at Syneos Health.

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Clinical Data Associate I (Inform)

Job Description

Clinical Data Associate I (Inform EDC)

About Syneos Health

Job Responsibilities

Clinical Data Management & Review

Data Entry & Quality Control (QC)

Study Tracking & Finalization

Additional Responsibilities

Required Qualifications

Why Join Syneos Health?

Join Us

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