Are you a skilled Clinical Professional with 3-6 years of experience, looking for a pivotal role in clinical trials? Biological E Limited, a leading name in the pharmaceutical and life sciences industry, is hiring a dedicated Clinical Trial Administrator for their Hyderabad location. This is a full-time, permanent position offering a fantastic opportunity to contribute to groundbreaking vaccine development.
Job Description at a Glance
- Role: Clinical Trial Administrator
- Company: Biological E Limited
- Experience: 3 – 6 Years
- Location: Hyderabad, Telangana, India
- Job Type: Full Time, Permanent
- Department: Research & Development (R&D)
- Category: Pharmaceutical & Biotechnology
Detailed Job Description
As a Clinical Trial Administrator at Biological E, you will be at the heart of the clinical operations team, ensuring the smooth execution and administration of clinical trials. Your role is critical in maintaining the integrity and compliance of the study documentation and processes.
Key Responsibilities & Roles:
You will be entrusted with a diverse set of tasks, including:
Clinical Trial Administration:
- Assist with Ethics and Regulatory Submissions, meticulously tracking their status and approvals.
- Support the medical team in preparing essential documents like Protocols, Investigator Brochures (IB), and Case Report Forms (CRF).
- Set up and maintain the Trial Master File (TMF), Investigator Site File (ISF), and other electronic filing systems.
- Manage and maintain all study documents and trial supplies, including patient information sheets, lab kits, and investigational products.
- Prepare, distribute, track, and file essential clinical trial documentation.
- Track budget utilization, process invoices, and manage payments for investigators.
- Coordinate the archiving of clinical development documents.
- Arrange for the translation of patient-related documents.
- Coordinate investigational vaccine procurement activities.
- Draft key clinical trial documents such as source documents, IB affidavits, and protocol overviews.
Clinical Data Management Coordination:
11. Assist in reviewing critical Clinical Data Management documents (eCRF, Data Management Plan, Edit Checks).
12. Conduct eCRF testing using dummy data to validate the clinical database.
13. Coordinate in eCRF query management and support the database lock process.
Additional Duties:
14. Assist Clinical Research Associates (CRAs) in their monitoring activities at clinical study sites.
Desired Candidate Profile
- Educational Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc in Life Sciences or a related field.
- Experience: 3 to 6 years of hands-on experience in clinical trials within the pharmaceutical or life sciences sector.
- Skills: Excellent communication skills are a must. The ideal candidate will have proven experience in the various administrative and coordination tasks listed above.
About Biological E Limited
Biological E Limited (BE) is a premier vaccine and pharmaceutical company based in Hyderabad, India. With a rich history spanning over six decades, BE has established itself as a global force in the production of life-saving vaccines and biological products. The company is deeply committed to research and development, focusing on addressing public health challenges and making healthcare accessible worldwide. Joining Biological E means becoming part of a team dedicated to scientific excellence and making a tangible impact on global health.
How to Apply
Interested and eligible candidates can apply for this Clinical Trial Administrator position through the original listing. You will need to register or log in to the platform where this job was posted to submit your application.