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Clinical Document Specialist

5+ years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Clinical Document Specialist

Location: India
Position: Full-time

Job Description:

The Clinical Document Specialist (CDS) will support Trial Master File (TMF) activities for clinical teams, ensuring the overall management and quality maintenance of clinical trial documents. The CDS will oversee both electronic and paper TMFs, adhering to project requirements, ICH GCP guidelines, regulatory standards, and Novotech SOPs. The role will also focus on managing routine document operations to maintain compliance and quality in clinical trials.

Key Responsibilities:

  • Act as a subject matter expert for TMF management, including uploading and quality control review of documents.
  • Serve as a liaison with clients and alliance partners regarding TMF responsibilities.
  • Contribute to team training programs and mentor new team members.
  • Lead potential process improvements in TMF management and workflows.
  • Stay updated on regulatory requirements related to TMF management.
  • Collaborate with project teams to develop Filing Plans and ensure customer satisfaction.
  • Ensure SOP requirements are met and resolve issues as needed.

Minimum Qualifications & Experience:

  • Education: Bachelor's degree in Life Sciences.
  • Experience: At least 5 years of experience in a clinical research organization or a similar role.
  • Practical experience in handling TMF activities (both paper and electronic-TMF).
  • Background in pharmaceutical, CRO, or healthcare industries is advantageous.
  • Familiarity with eTMF systems is essential.

About Novotech:

Novotech is a leading Asia-Pacific-based clinical research organization (CRO) specializing in biotech. With offices across 11 geographies, Novotech has extensive experience in clinical trial phases and therapeutic areas. The company is committed to providing a supportive and inclusive work environment with flexible working options and employee development opportunities. Novotech supports gender equality and diversity and encourages applications from all backgrounds, including LGBTIQ+ individuals, people with disabilities, and those with caregiving responsibilities.

Perks & Benefits:

  • Flexible work environment.
  • Paid parental leave for both parents.
  • Wellness programs.
  • Ongoing professional development programs.