Clinical Data Associate I
Updated: March 13, 2025
Location: India – Asia Pacific (Home-Based)
Job ID: 25002203
Description:
Syneos Health® is a fully integrated biopharmaceutical solutions organization, accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model brings both the customer and the patient to the center of everything we do.
We seek a Clinical Data Associate I who is passionate about simplifying processes, driving innovation, and making a global impact.
Why Syneos Health:
Focus on career development and progression with supportive management and extensive training.
Commitment to fostering a Total Self Culture where employees can authentically be themselves.
A diverse and inclusive environment where every perspective adds value.
Job Responsibilities:
Maintain awareness of pertinent contract elements and scope of work for assigned projects.
Review and adhere to study-specific Clinical Data Management Plans (DMP) for assigned projects.
Receive and enter lab normal ranges into the system.
Complete and submit Clinical Database Management System (CDMS)-specific access forms and spreadsheets.
Review discrepancy (edit check) output and validation listings, apply self-evident corrections, and resolve answered queries based on DVS and DMP.
For paper studies:
Review and edit Case Report Forms (CRFs) based on Data Clarification Forms (DCFs) received.
Perform internal QC checks using listing output from the database.
Return all CRFs and DCFs to the Document Control Room (DCR) per Data Tracking Guidelines.
For paper and hybrid studies:
Serve as backup for data entry.
Conduct pre-review and QC review of CRFs using an image system.
For EDC studies:
Perform data management quality reviews and internal QC checks based on EDC system requirements.
Track project progress and issue periodic status reports.
Support in finalizing and transferring clinical databases and project documents to the sponsor.
Identify milestones and ensure timely achievement of project goals.
Create electronic storage media per SOPs for EDC studies.
Participate in internal meetings, audits, and inspections as required.
File documentation in the Data Management Study File (DMSF) and assist with study archival.
Maintain proficiency in DM systems and processes through regular training.
Understand the coding process and purpose of interim, dry run, and data cut.
Qualifications:
Education:
BA/BS degree in biological sciences or related disciplines in the natural science/healthcare field.
Experience:
1-2 years of experience in Clinical Data Management.
Strong proficiency in end-to-end DM practices with good knowledge of Rave EDC tool.
Therapeutic area experience in Oncology, Cardiology, Immunology, or Gastrointestinal studies preferred.
Conduct phase experience is required, setup and closeout experience is an advantage.
Familiarity with DM practices and relational database management systems.
Preferred experience with Oracle Clinical, Rave, or Inform systems.
Knowledge of ICH/Good Clinical Practices (GCP) and medical terminology.
Technical Skills:
Proficiency in Microsoft Windows, Word, Excel, and email applications.
Excellent keyboard skills with speed and accuracy.
Soft Skills:
Strong communication, presentation, and interpersonal skills.
Ability to multitask under tight deadlines while ensuring attention to detail.
Strong organizational, planning, and time management skills.
Ability to work independently and within a multi-disciplinary team.
Additional Requirements:
Compliance with Corporate Business Practices, SOPs, and Working Instructions.
Ability to travel occasionally (up to 25%).
About Syneos Health:
Over the past 5 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.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore |Uttar Pradesh :
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Birmingham |Alaska :
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Hangzhou |Melbourne :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
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Jeddah | King Abdullah Economic City | Khulais | Riyadh | Najran | Rabigh |Nišava District :
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