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Clinical Data Associate

1-2 years
Not Disclosed
10 Feb. 24, 2025
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

Position: Clinical Data Associate I
Location: Bangalore, India
Job Category: Data Management


Role Overview:

The Clinical Data Associate I will support day-to-day operations of data management projects. This includes providing in-house data entry support, assisting in data validation, and providing administrative support to Clinical Data Managers (CDMs), in alignment with GCDMP guidelines, local regulatory requirements, and Novotech/Client SOPs.


Key Responsibilities:

The Clinical Data Associate I will be involved in the following:

  • Data Entry: Enter clinical trial data into Clinical Data Management (CDM) software.

  • Data Queries: Assist in the review and resolution of data queries raised by sponsor companies/monitoring staff.

  • Tracking: Track CRF pages received, data queries sent/received, and data entered.

  • Database Support: Assist with database testing and the testing of edit checks.

  • Data Cleaning/Validation: Support data cleaning, validation, and reconciliation of external data sources.

  • Reporting: Assist CDM in generating reports, listings, and other project outputs.

  • Study Progress: Help maintain systems to track study progress, including safety reports and Novotrak updates.

  • Meetings and Documentation: Attend project meetings and assist with writing agendas and minutes for data management teams.

  • Administration: Provide general administrative support to the Data Management team as required.

  • Professional Development: Participate in professional forums, conferences, and associations for development and promoting Novotech's image.

  • Process Improvement: Actively contribute to company process improvement initiatives.


Minimum Qualifications & Experience:

Education:

  • A graduate degree in a clinical or life sciences-related field.

  • Relevant experience/qualifications in allied professions may also be considered.

Experience:

  • At least 6 months to 1 year of experience in research, the pharmaceutical industry, or a related field.


Desired Skills & Competencies

  • Strong understanding of clinical data management, data entry, and validation processes.

  • Ability to use Clinical Data Management software.

  • Knowledge of GCDMP, ICH-GCP, and relevant regulatory requirements.

  • Effective communication skills to collaborate with project teams and stakeholders.

  • Time management skills, with the ability to manage multiple tasks efficiently.


About Novotech:

Novotech is a global, full-service Clinical Contract Research Organization (CRO) offering comprehensive services across all clinical trial phases and therapeutic areas. Headquartered in Sydney, Australia, Novotech has 34 offices across the Asia-Pacific, North America, and Europe. We are committed to delivering high-quality clinical development services, with a focus on ISO 27001 and ISO 9001 certifications for IT security and quality.


Employee Benefits:

At Novotech, we provide a supportive and inclusive work environment, with benefits such as:

  • Flexible working options.

  • Paid parental leave for both parents.

  • Wellness programs and ongoing development opportunities.

We support diversity in the workplace and encourage applications from all backgrounds, including LGBTIQ+ individuals, people with disabilities, and those with caregiving responsibilities.


Application Details:

Location: Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore, 560103, India
Job Schedule: Full Time
Apply By: 28th February 2025


For more details or to apply, click on Apply Now and follow the application process.


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