Clinical (Medidata Rave) Coder – Remote at Dice | United States 2023

Clinical (Medidata Rave) Coder

Location: Remote

Department: Clinical Data Management

Summary:

At TK-CHAIN, our mission is to drive excellence across all facets of the life sciences domain. We are seeking a skilled and diligent Medical Coder to join our dynamic team. The ideal candidate will have a strong background in medical coding, particularly in the context of clinical trials and regulatory compliance. This role will be pivotal in optimizing the IMC coding process within Medidata RAVE and collaborating with various internal teams to ensure data integrity and regulatory alignment.

Key Responsibilities:

1. Develop Coding Process for IMC in Medidata RAVE:
   • Lead the design, development, and implementation of a robust coding process tailored to IMC specifications within the Medidata RAVE environment.
   • Ensure adherence to best practices and industry standards.
2. Regulatory Document Management:
   • Design, develop, and manage all essential coding documents necessary for regulatory compliance.
   • Coordinate with the regulatory team to ensure timely submission and updates.
3. Cross-Functional Collaboration:
   • Engage closely with Medical Monitors, Pharmacovigilance teams, and Clinical Scientists to foster coding collaboration.
   • Facilitate discussions and meetings to address any discrepancies or challenges.
4. IMC URL Impact Analysis:
   • Conduct thorough impact analysis of coding across all IMC studies on IMC URL, at least 2-3 times a year.
   • Report findings and recommend any necessary modifications.
5. Lead Coding Responsibilities:
   • Act as the assigned lead Coder for new studies, ensuring that coding standards are consistently met.
   • Possibly oversee coding for ID studies, collaborating with study leads and data management teams.

Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Certified Professional Coder (CPC) or equivalent certification is desirable.
• Proficiency in Medidata RAVE or similar EDC systems.
• Minimum of 7 years of experience in medical coding, preferably in a clinical research setting.
• Strong understanding of clinical trial processes and regulatory requirements.
• Excellent interpersonal and communication skills.
• Detail-oriented with a commitment to accuracy.

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