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The internship program provides learning experience, mentoring and valuable work experience in the field of clinical trials. We provide our interns the opportunity to work on meaningful assignments and make sure that they gain real world experiences (in the areas of Regulatory & Finance and Supply & CRA support).



This program provides comprehensive trial and site administration experience. Under the oversight of the COM Lead/COMs and CTCs, the person prepares, collates, distributes and archives clinical documents. The Interns supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

* Internship duration up to 12 months *

Responsibilities:

Trial and site administration:

Track (e.g. essential documents) and report (e.g. Safety Reports)

Ensure collation and distribution of study tools and documents

Update clinical trial databases (CTMS) and trackers

Clinical supply & non-clinical supply management, in collaboration with other country roles

Manage Labeling requirements and coordinate/sign translation change request

Document management:

Prepare documents and correspondence

Collate, distribute/ship, and archive clinical documents, e.g. eTMF

Assist with eTMF reconciliation

Execute eTMF Quality Control Plan

Update manuals/documents (e.g., patient diaries, instructions)

Document proper destruction of clinical supplies.

Prepare Investigator trial file binders

Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

Obtain, track and update study insurance certificates

Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

Publish study results for GCTO and RA where required per local legislation

We are looking for a nonclinical lead with a toxicology and nonclinical drug development background to join our team. The role involves managing all nonclinical studies, scientific review of study plans, regulatory document review and writing, and participation in strategic discussions.

Key Responsibilities
Management and monitoring of all non-clinical studies
Review and oversee nonclinical studies Provide expert evaluation and guidance on nonclinical study plans and reports.
Regulatory support Review regulatory documents as a nonclinical SME and contribute to regulatory writing (IB, submission documents) as needed.
Strategic input in nonclinical development Offer expert guidance on nonclinical development strategies.
Participation in team meetings provide updates on study monitoring
Expert consultation Take part in dedicated expert meetings as needed.