This role is responsible for comprehensive trial and site administration.

Under the oversight of the Senior COM or COMs or CTC Manager, the person prepares, collates, distributes and archives clinical documents.

The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities.

The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Secondary Language(s) Job Description**:

Responsibilities include, but are not limited to:

• Trial and site administration:

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

oEnsure collation and distribution of study tools and documents

oUpdate clinical trial databases (CTMS) and trackersoClinical supply & non-clinical supply management, in collaboration with other country roles

oManage Labeling requirements and coordinate/sign translation change request

• Document management:

oPrepare documents and correspondenceoCollate, distribute/ship, and archive clinical documents, e.g. eTMF oAssist with eTMF reconciliationoExecute eTMF Quality Control PlanoUpdate manuals/documents (e.g., patient diaries, instructions)

oDocument proper destruction of clinical supplies.

oPrepare Investigator trial file bindersoObtain translations of documents

• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:oIn a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site startup and submissions

oObtain, track and update study insurance certificates

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

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

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

07/18/2024

Job Posting End Date:
07/18/2024

Requisition ID:
R300360

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