Sr Cda

6-8 years

Not Disclosed

India Remote

10 Dec. 5, 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

Here’s a rewritten version of the Senior Clinical Data Associate (Sr CDA) job description for clarity and flow:

Senior Clinical Data Associate
Updated: November 29, 2024
Location: India-Asia Pacific - Home-Based, India
Job ID: 24006360

About Syneos Health
Syneos Health® is a leading, fully integrated biopharmaceutical solutions provider committed to accelerating customer success. We leverage our clinical, medical affairs, and commercial expertise to translate insights into actionable outcomes, addressing modern healthcare challenges.

Our Clinical Development model focuses on putting the customer and the patient at the center of everything we do. We are always looking for ways to simplify and streamline our processes, making Syneos Health easier to work with and for.

As part of our team, you'll collaborate with passionate problem solvers, continuously innovating to help our customers achieve their goals. We are driven by our mission to accelerate the delivery of therapies and make a positive impact on patients' lives.

Why Join Syneos Health

Career Growth: We are committed to developing our people through career progression, ongoing technical and therapeutic training, and a total rewards program.
Inclusive Culture: Our Total Self culture encourages everyone to bring their authentic selves to work, promoting diversity and a sense of belonging.
Global Impact: Join a company involved in 94% of all novel FDA-approved drugs and 95% of EMA-authorized products over the past five years.

Job Responsibilities

Maintain awareness of project contract and scope of work, communicating status updates to the Project Manager (PM) or Biometrics Project Manager (BPM) as needed.
Review and adhere to study-specific Data Management Plans (DMP), updating them as required.
Create and enter test data for User Acceptance Testing (UAT) of data entry screens and review listings.
Perform UAT for study-related data configurations, including Source Data Verification (SDV) matrices.
Enter and review lab normal ranges in the system.
Perform reviews of discrepancy outputs and validation listings, applying self-evident corrections and queries as per study protocols.
For paper studies, review and edit Clinical Data Forms (CRFs) and Data Clarification Forms (DCFs) as needed.
Ensure that all CRFs and DCFs are appropriately filed and documented in accordance with study guidelines.
Conduct internal quality checks (QC) for both paper and Electronic Data Capture (EDC) studies.
Participate in internal/external audits and in-process review meetings.
Maintain comprehensive study documentation in the Data Management Study File (DMSF).
Perform quality control (QC) checks on data from external databases to ensure consistency with clinical database entries.
Provide data cleaning reports and monitor the resolution of discrepancies.
Ensure the timely completion of tasks while prioritizing effectively across multiple projects.
Perform Serious Adverse Event (SAE) reconciliations.
Liaise with teams in Clinical Programming (CP), Biostatistics, and Clinical Operations to ensure data consistency.
Lead and mentor junior Data Management staff, providing on-the-job training and feedback.
Provide expertise in EDC training to internal and external teams.
Review and design study-specific documents, including CRF/eCRF, DMP, and data import/export agreements.
Participate in sponsor meetings, ensuring timely distribution of meeting minutes and updates.
Perform post-migration testing and assist with database design reviews.
Serve as a Subject Matter Expert (SME) for platform- or process-specific queries.
Participate in client audits and inspections as needed.

Qualifications

Education: Bachelor’s degree in biological sciences or related disciplines.
Experience: 6 to 8 years of experience in Clinical Data Management, with expertise in trial conduct and closeout phases.
Hands-on experience in data cleaning, vendor reconciliation, and SAE reconciliation.
Leadership experience in managing Data Management activities and teams.
Proficiency with Data Management software systems (e.g., Oracle Clinical, Rave, Inform) preferred.
Knowledge of clinical data, ICH/Good Clinical Practices (GCP), and medical terminology.
Proficient in Microsoft Word, Excel, and email applications.
Strong communication, presentation, and interpersonal skills, with an ability to inform and persuade effectively.
Excellent organizational, planning, and time management abilities, with attention to detail and the ability to multitask under tight deadlines.
Ability to mentor and manage teams, including sponsors and internal customers.
Travel: Minimal travel required (up to 25%).

Get to know Syneos Health
Over the past five years, we’ve supported 94% of all novel FDA-approved drugs and 95% of EMA-authorized products across 200+ studies and 675,000+ trial patients.

At Syneos Health, we’re constantly evolving and challenging the status quo. Learn more about how we’re shaping the future of biopharmaceutical solutions.

Additional Information:
This job description provides a general overview of responsibilities and qualifications but is not exhaustive. Tasks and duties may be assigned based on the needs of the company, and equivalent experience or skills may be considered in lieu of specific qualifications.

Syneos Health is committed to equal opportunity and compliance with all applicable legislation, including the Americans with Disabilities Act (ADA), and will provide reasonable accommodations when necessary.

This revision provides a more concise and structured overview of the role while maintaining the necessary details for clarity and impact. Let me know if you'd like any further adjustments!

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Sr Cda

Job Description

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