Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office

Coding Spec:
Join Us as a Clinical Data Associate I - Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 Bio-techs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
Role Overview:
As a Coding Specialist, you will ensure high?quality, compliant coding of clinical and medical terminology using established standards and the study Coding Plan. You will review coding listings, identify and resolve data issues with study teams and sites, and deliver accurate, on?time coding outputs aligned to SOPs, GCP, and DVMs. Partnering with CDM project teams, you will provide guidance on coding practices, maintain documentation, and produce regular status reports to support inspection?ready, analysis?ready data.
What You'll Do:

• Code medical terminology and review coding listings in accordance with the Coding Plan in the DVM.
• Identify data issues and work with Thermo Fisher team and study sites to resolve.
• Ensure coding accuracy according to departmental operating procedures.
• Ensure all coding aspects are conducted accurately, and all coding deliverables are completed to quality expectations, within budget and on time.
• Provide support, guidance and direction on all coding aspects to the CDM project team.
• Produce project-specific status reports for supervisor and for clients on a regular basis.

Education and Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic
• Previous experience (Min 1 to 1.6 Years) that provides the knowledge, skills, and abilities to perform the job
• Should have experience in RAVE / Veeva EDC, WHODD, MEDDRA Coding dictionaries

Knowledge, Skills and Abilities:

• Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
• Excellent understanding of clinical/medical terminology with strong attention to detail
• Ability to use interactive computer programs.
• Good written and verbal communication skills and a strong command of English language and grammar
• Good organizational and analytical/problem-solving skills
• Ability to work productively with minimal supervision
• Ability to maintain a high degree of confidentiality with medical records and client's proprietary data
• Strong customer focus and excellent interpersonal skills.
• Proven flexibility and adaptability, able to work in a team environment and independently as needed
• Must demonstrate good judgment in making decisions
• Understands project protocol and Data Validation Manual

Your Career Growth:
We are hiring a team in India to support our FSP client - a large, globally recognized biopharmaceutical organization with a strong legacy in specialty medicines, vaccines, and scientific innovation. This sponsor is known for its commitment to patients, global research and development, and long-term investment in science. As a client dedicated FSP employee, you will collaborate with our client's global data science team, contribute to complex and high visibility initiatives, and work within a mature FSP delivery model focused on quality and partnership
Our FSP model supports continuous learning and career development by offering employees tailored learning pathways, stretch assignments, and mentorship - this allows FSP professionals to expand their horizons. This role opens multiple career paths. You could progress along the Clinical Data Management track (e.g., Senior CDM, CDTL, CDM PM) or transition into Data Standards/Programming, based on skill, impact, and business need.
Why You'll Want to Join:

• Join our FSP Data Management team and help bring life?changing medicines to patients worldwide. Accelerate your growth with hands?on experience in modern CDM, from EDC and data quality to AI?enabled workflows--building the expertise to lead data?driven study delivery in a rapidly evolving clinical landscape
• Global exposure:

Work on international clinical studies across phases and therapeutic areas, partner with global teams, CROs, vendors, and country operations.

• End-to-end ownership:

Contribute to every stage of study delivery, from set-up to close-out.

• Analytical & project skills:

Strengthen global project management, financial tracking, data analysis, and risk management abilities. Learn new clinical trial technologies like AI platforms to conduct a global clinical trial
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or making their laboratory work more efficient, we are here to support them. Our distributed team of more than 90,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit . Thermo Fisher Scientific is a Equal employment opportunity

Skills Required