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Sr Cda (Data Acquisition Specialist-Non-Crf)

5-7 years
Not Disclosed
10 Sept. 19, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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: Sr CDA (Data Acquisition Specialist-Non-CRF)

Updated: September 10, 2025
Location: IND – Pune
Job ID: 25101587


About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. With 29,000 employees across 110 countries, we focus on innovation, collaboration, and patient-centered clinical development.

Work Here Matters Everywhere – We foster career growth, supportive leadership, technical and therapeutic training, and a diverse, inclusive culture where everyone belongs.


Job Summary

The Sr CDA (Data Acquisition Specialist – Non-CRF) is responsible for leading Clinical Data Associates in the collection, management, and oversight of non-CRF data during study setup, conduct, and closeout for multiple studies. The role may also act as a backup for the Project Data Manager (PDM) and ensures accuracy, compliance, and smooth delivery of non-CRF data management activities.


Core Responsibilities

Study Setup & Data Management

  • Lead and oversee non-CRF data setup and acquisition activities across multiple studies.

  • Review study-specific Data Management Plans (DMP) and update as required.

  • Create and test User Acceptance Testing (UAT) scenarios for EDC systems, edit checks, and Targeted Source Data Verification (SDV).

  • Review CRF/eCRF design, visit structure, and database specifications.

  • Implement and approve Non-CRF Vendor Transfer Agreements/plans/specifications.

  • Conduct post-migration testing and database validation activities.

Data Processing & Quality Control

  • Receive, process, and deliver non-CRF test and production data (eCOA, ePRO, device/sensor, ECG, central lab, IWRS/IVRS).

  • Perform data discrepancy checks, self-evident corrections, query management, and Serious Adverse Event (SAE) reconciliation.

  • Run data cleaning/status reports and generate ad-hoc data reports.

  • Ensure external vendor datasets (lab, diary, PK, IRT, etc.) align with clinical database data.

  • Perform QC of study documentation and Data Management Study File (DMSF).

Collaboration & Leadership

  • Lead cross-functional collaboration with Clinical Programming, Biostatistics, Clinical Operations, and vendors.

  • Act as the Non-CRF Point of Contact (POC) for customers, leading vendor communication and cross-functional tasks.

  • Support and back up PDMs, including sponsor updates, study metrics reporting, and resource coordination.

  • Provide EDC and project-specific training to internal/external teams.

  • Mentor and supervise other Clinical Data Associates, reviewing and guiding their work.

Compliance & Documentation

  • Participate in internal/external audits and inspections.

  • Maintain inspection-ready documentation in compliance with SOPs, GCP, ICH, and corporate guidelines.

  • Prepare reports such as SDRG/ADRG, DVS updates, and validated listing specifications.


Qualifications

Education

  • Bachelor’s degree in Biological Sciences, Natural Sciences, Health Care, or related field.

Experience

  • 5–7 years of Clinical Data Management experience.

  • Strong background in non-CRF setup and external vendor data management.

  • Hands-on experience with central lab, eCOA, ePRO, patient diaries, device/sensor testing, ECG, IWRS/IVRS setup.

  • Knowledge of relational databases and Data Management systems (Oracle Clinical, Rave, Inform preferred).

  • Familiarity with medical terminology, ICH/GCP, and clinical trial processes.

Skills

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

  • Excellent communication, interpersonal, and presentation skills.

  • Strong organizational and time management abilities; able to multitask under tight deadlines.

  • Leadership skills with proven mentoring and sponsor-facing experience.

  • Flexibility and adaptability to changing priorities.


Additional Information

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

  • Responsibilities listed are not exhaustive; other duties may be assigned as per business needs.

  • Syneos Health values diversity, inclusion, and transferable skills – candidates are encouraged to apply even if not meeting every requirement.