Cda Ii

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 II at Syneos Health

About Syneos Health

Syneos Health is a globally integrated biopharmaceutical solutions organization committed to driving innovation and customer success. Our clinical development model prioritizes patients and customers, streamlining workflows for efficiency and effectiveness. Join a team of 29,000 professionals in over 110 countries who are passionate about changing lives.

At Syneos Health, “Work Here Matters Everywhere.”

Key Responsibilities

Data Management and Quality Assurance

Execute User Acceptance Testing (UAT) for data entry screens, edits, and data review listings.
Manage lab normal range data entry and clinical database system (CDMS) access forms.
Review discrepancy outputs, issue queries, and apply corrections per the Data Validation Specification (DVS) and Data Management Plan (DMP).
Ensure consistency between clinical databases and external datasets like labs, PK data, and electronic diaries.
Conduct Serious Adverse Event (SAE) reconciliations and perform data cleaning tasks.

Study Coordination and Documentation

Manage paper study data, including Data Clarification Forms (DCFs), Case Report Forms (CRFs), and internal quality checks.
Oversee electronic storage media for Electronic Data Capture (EDC) studies and ensure document filing in the Data Management Study File (DMSF).
Participate in internal and external meetings, including audits and team updates.
Develop and review study-specific guidelines, data tracking, and test data for Standard Data Tabulation Model (SDTM).

Process Improvement and Training

Stay updated on data management systems and processes via regular training.
Mentor and provide guidance to team members on data management activities and systems.
Proactively adjust to changing priorities, ensuring deadlines are met with high-quality outputs.

Qualifications

Education and Experience

Bachelor’s degree in biological sciences, natural sciences, or a healthcare-related field.
Experience with clinical data management, clinical research, or drug development preferred.

Technical Skills

Familiarity with Oracle Clinical, Rave, or Inform systems is a plus.
Strong proficiency in MS Windows, Word, Excel, and email applications.

Soft Skills

Excellent communication and interpersonal skills, with an ability to collaborate effectively.
Strong organizational and multitasking skills, with attention to detail.
Adaptable to change and capable of working independently and in a team setting.

Additional Requirements

Familiarity with medical terminology and ICH/Good Clinical Practices preferred.
Minimal travel required (up to 25%).

Why Syneos Health?

Career Development

Supportive management, technical training, peer recognition, and career progression opportunities.

Inclusive Culture

A Total Self culture that values diversity, inclusion, and authenticity.

Global Impact

Join a team that has contributed to 94% of all FDA-approved novel drugs and worked with over 200 studies.

Application Details

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

Syneos Health values diversity and encourages applicants with transferable skills and experiences.

For more information about Syneos Health, visit our website and start your journey to making a global impact. Join us in transforming lives.

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