Senior Clinical Trial Coordinator

hace 2 semanas

Ciudad de México, Ciudad de México MSD A tiempo completo

Job Description

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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 start-up 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
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/7/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:06/07/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R292325

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