Novotech Global is seeking a Clinical Document Specialist (CDS) to join their team in India. This position involves managing clinical data for pharmaceutical and biotech companies, ensuring data accuracy and compliance with regulatory standards.
The Clinical Document Specialist (CDS) will provide support for Trial Master File (TMF) activities to the clinical teams for assigned projects. This role will be responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF).
The CDS will have a strong focus on ensuring routine document management operations are performed with adherence to Novotech SOPs. This role to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines, local/global regulatory requirements, and Novotech/Client SOPs.
Exciting CDS Job Opportunity at Novotech Global for BSc in Life Sciences
| Attribute | Details |
|---|---|
| Position | Senior Clinical Data Manager |
| Location | India |
| Key Responsibilities | Manage clinical data activities, oversee data collection, ensure data quality and integrity, and liaise with project teams. |
| Minimum Qualifications | Bachelor’s degree in Life Sciences or related field; experience in clinical data management; knowledge of CDISC standards. |
| Experience | Minimum 5 years in clinical data management with expertise in EDC systems and regulatory compliance. |
| Skills | Strong analytical skills, attention to detail, excellent communication, and proficiency in data management software. |
| Employment Type | Full-time |
| Application Deadline | Not specified |
How to Apply
Interested candidates can apply online through the Novotech Global Career Portal.
General Information/Guidelines
- Eligibility: Ensure you meet the minimum qualifications and experience requirements.
- Application Process: Submit your application through the online portal, ensuring all required documents and information are included.
- Selection Process: Shortlisted candidates will be contacted for further selection processes.
- No Interim Inquiries: Avoid contacting the hiring team directly for application status updates.
- Immediate Joining: Selected candidates should be ready to join immediately upon receiving the offer.
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