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Associate Clinical Data Manager - 12 Month Contract

2+ years
Not Disclosed
10 Dec. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Title: Associate Clinical Data Manager (12-Month Contract)
Location: India

Job Description:

We are seeking an Associate Clinical Data Manager (ACDM) to join Novotech's Data Management group on a 12-month contract. As an ACDM, you will be responsible for managing all aspects of data management under the guidance of a senior Clinical Data Manager (CDM) or Line Manager, ensuring compliance with Good Clinical Data Management Practices (GCDMP).

Key Responsibilities:

  • Project Support: Act as a member of the project team, reporting to the Biometrics Project Manager/Project Manager. Oversee the planning, conducting, and management of all data management aspects for a clinical trial, ensuring compliance with project specifications, Data Management Plans, regulatory requirements, and SOPs.
  • Data Management Tasks:
    • Design and review database structures, validation rules, and consistency checks.
    • Manage data entry, data cleaning, and validation tasks.
    • Develop key Data Management Documents.
  • Collaboration & Communication:
    • Liaise with project teams, clients, and external service providers to maintain effective study communication.
    • Support the development of protocols and provide input into RFP preparation.
  • Financial Management: Perform accurate study financial projections and maintain monthly project financials, ensuring changes in scope are identified and addressed.
  • Process Improvement & Training: Contribute to business development, process improvement initiatives, and support the training of junior and contract Data Management staff.
  • Industry Engagement: Participate in industry forums and conferences for professional development and to promote Novotech’s image in the industry.

Qualifications:

  • Education: Graduate in a clinical or life sciences-related field.
  • Experience: 3-6 years of experience in a Clinical Data Associate or equivalent role in the pharmaceutical industry or a related field.
  • Skills: Strong data management experience, ability to perform comprehensive data review, query management, and external data reconciliation. Experience in project management and working with Clinical Data Management software is essential.

Why Novotech?

Novotech is committed to offering a great workplace, focusing on gender equality and providing an inclusive work environment where all team members are treated fairly and with respect. We support flexible working options, wellness programs, paid parental leave for both parents, and ongoing development opportunities.

We welcome applicants from all backgrounds, including LGBTIQ+ individuals, people with disabilities, and those with caregiving responsibilities.