Cda Iii (Central Lab)

1+ years

Not Disclosed

India

10 Nov. 29, 2024

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

Job Opportunity: Clinical Data Associate III at Syneos Health

About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions organization that accelerates customer success by delivering clinical, medical affairs, and commercial insights. Join a global team of 29,000 professionals across 110 countries who are passionate about transforming lives.

At Syneos Health, “Work Here Matters Everywhere.”

Key Responsibilities

Data Management and Quality Control

Lead and perform User Acceptance Testing (UAT) for data entry screens, edits, and targeted SDV configurations.
Review discrepancy outputs, apply self-evident corrections, and issue queries as per the Data Validation Specification (DVS) and Data Management Plan (DMP).
Ensure consistency and accuracy of data from external sources, such as labs, e-diaries, and PK data.
Conduct SAE reconciliations and QC reviews of data dictionaries and ad-hoc data cleaning reports.

Coordination and Oversight

Supervise and mentor Clinical Data Associates (CDAs) on project-specific tasks and data management systems.
Coordinate project activities, including database design, eCRF visit structure, and CRF completion guidelines.
Serve as a backup for the Project Data Manager (PDM) for certain tasks, including sponsor updates and document reviews.
Actively participate in internal/external meetings, providing updates and distributing minutes.

Documentation and Reporting

Create, update, and manage documents such as the DMP, data import/export agreements, and eCRF guidelines.
Prepare Data Transfer Request Forms for data delivery to sponsors or vendors.
Generate and review data cleaning and status reports to support ongoing project needs.

Continuous Improvement and Compliance

Maintain proficiency through regular training on data management systems and processes.
Adapt to evolving timelines and priorities by reorganizing workloads and minimizing rework.
Ensure compliance with ICH/GCP guidelines, corporate business practices, and standard operating procedures.

Qualifications

Education and Experience

Bachelor’s degree in biological sciences or a related healthcare field.
Experience in data management, clinical research, or drug development.
Proficiency with Oracle Clinical, Rave, or Inform systems preferred.

Technical Skills

Advanced proficiency in MS Windows, Word, Excel, and email systems.
Familiarity with medical terminology and relational database management.

Soft Skills

Strong organizational, multitasking, and problem-solving abilities.
Excellent communication, presentation, and interpersonal skills.
Ability to work independently and collaboratively in a multidisciplinary team.

Additional Requirements

Minimal travel (up to 25%) may be required.
Flexible and adaptive to change, with attention to detail and time management.

Why Join Syneos Health?

Career Growth

Comprehensive professional development programs, peer recognition, and career progression opportunities.

Inclusive Culture

Thrive in a Total Self culture, fostering authenticity and diversity in thought and perspective.

Global Impact

Be part of a team delivering cutting-edge therapies that transform lives worldwide.

Application Details

Apply Now on Syneos Health's career portal.
Not ready to apply? Join the Talent Network for updates on future opportunities.

Syneos Health values transferable skills and encourages applications from all qualified candidates.

For more information, visit Syneos Health’s website and start your journey toward making a global impact. Be part of the change.

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