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Clinical Data Associate Ii (Inform)

2+ years
Not Disclosed
10 March 28, 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 II (Inform) - India-Asia Pacific - IND-Home-Based

Updated: March 26, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002256

Description
Clinical Data Associate II (Inform)

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 continuously seek to simplify and streamline our work to make Syneos Health easier to work with and 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:

  • Career development and progression.

  • Supportive and engaged line management.

  • Technical and therapeutic area training.

  • Peer recognition and total rewards program.

  • Committed to a Total Self culture where you can authentically be yourself.

Job Responsibilities:

  • Maintains awareness of contract elements and scope of work for assigned projects.

  • Reviews and adheres to Clinical Data Management Plans.

  • Creates and enters test data for User Acceptance Testing (UAT).

  • Performs UAT for data entry screens, edits, and review listings.

  • Receives and enters lab normal ranges.

  • Completes and submits CDMS-specific access forms/spreadsheets.

  • Reviews and resolves discrepancies in edit checks and validation listings.

  • Manages Data Clarification Forms (DCFs) and updates Case Report Forms (CRFs) accordingly.

  • Performs internal QC checks for paper studies.

  • Ensures proper filing of CRFs and DCFs in the Document Control Room.

  • Conducts DM quality review and QC checks for EDC studies.

  • Creates electronic storage media as per SOPs for EDC studies.

  • Participates in internal meetings and audits.

  • Files documentation in the Data Management Study File (DMSF).

  • Maintains proficiency in Data Management systems and processes.

  • Creates and enters test data for SDTM.

  • Conducts SAS mapping QC.

  • May coordinate the work of CDAs and provide training.

  • Ensures consistency of external databases with clinical database data.

  • Manages task prioritization and meets deadlines while communicating availability and workload to project teams.

  • Runs data cleaning and status reports.

  • Performs Serious Adverse Event (SAE) reconciliations.

  • Understands the coding process and interim, dry run, and data cut procedures.

Qualifications:

  • BA/BS degree in biological sciences or related natural science/healthcare disciplines.

  • Experience with DM practices and relational database management preferred.

  • Preferred experience with Inform systems and clinical data knowledge.

  • Proficiency in MS Windows, Word, Excel, and email applications.

  • Strong keyboard skills with excellent speed and accuracy.

  • Experience in clinical research, drug development, or data management preferred.

  • Familiarity with medical terminology.

  • Excellent communication, presentation, and interpersonal skills.

  • Strong organizational, planning, and time management skills.

  • Ability to multitask under tight deadlines while ensuring attention to detail.

  • Flexibility and adaptability to change.

  • Ability to work independently and as part of a multidisciplinary team.

  • Compliance with Corporate Business Practices, SOPs, and Working Instructions.

  • Minimal travel may be required (up to 25%).

Get to Know Syneos Health:
Over the past 5 years, Syneos Health has 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.

Additional Information:
Tasks, duties, and responsibilities listed in this job description are not exhaustive. Syneos Health may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and education will be considered.