Global Clinical Trial Operation Emerging Talent Rotation Associate

Job Description

Under the oversight of the line-manager mentor and / or rotational assignment manager this position involves a 24-36 month committed experience rotating throughout Research and Development Division / Global Clinical Trial Operations in various clinical trial functions in preparation for movement into next roles.

This role will collaborate throughout Global Clinical Trial Operations local country and HQ levels with trial management data management country operations and other areas. This role will rotate through various organizations teams and functions within Research and Development Division and Global Clinical Trial Operations to gain broad clinical research exposure and experience in support of clinical trial execution.

The role assists in meeting Site Ready objectives IRB / ERC and Health Authorities submissions study execution objectives data management responsibilities clinical / non-clinical supply management and ensures timely maintenance of tracking and reporting tools as applicable in support of clinical trial delivery.

Responsibilities may include but are not limited to :

Trial and site administration and management :

Track essential documents and report issues as applicable

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 in collaboration with other country roles (if applicable)

Document and data 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

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 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.

Budgeting Agreement and Payments :

Collaborate with finance / budgeting representatives to :

Maintain contracts (e.g. CTRAs)

Track and report contract negotiations

Update and maintain contract templates (in cooperation with Legal Department)

Monitor and track adherence and disclosures

Maintain tracking tools

Obtain and process FCPA documentation in a timely manner

Meeting Attendance & Planning :

Organize meetings (create & track study memos / letters / protocols

Support local investigator meetings where applicable

Skills :

Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills

Good understanding of Global Country / Regional Clinical Research Guidelines and ability to work within these guidelines

Proficient IT skills (Use of MS office use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.

ICH-GCP Knowledge appropriate to role

Effective time management organizational and interpersonal skills conflict management

Effective communication with external customers (e.g. sites and investigators)

High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

Demonstrates commitment to customer focus both internally and externally.

Able to work independently

Proactive attitude to solving problems / proposing solutions

Experience Requirements :

Clinical Research relevant healthcare or transferrable experience / skills preferred.

Educational Requirements :

High School Diploma or equivalent with completed job training (office management administration finance life sciences engineering project management healthcare education preferred) required.

Bachelors Degree preferred.

#MSJR

Required Skills :

Adaptability Adaptability Clinical IT Clinical Research Management Clinical Study Design Clinical Trial Agreements (CTA) Clinical Trial Compliance Clinical Trial Management Clinical Trials Contract Lifecycle Management (CLM) Contract Management Customer-Focused Data Analysis Data Management Document Management Good Clinical Data Management Practice (GCDMP) ICH GCP Guidelines Medical Research Medical Supply Management New Technology Integration Office Administration Project Management Regulatory Compliance Regulatory Submissions Supply Change Management 1 more

Preferred Skills :

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Employee Status : Regular

Relocation : No relocation

VISA Sponsorship : No

Travel Requirements :

10%

Flexible Work Arrangements :

Remote

Shift : 1st - Day

Valid Driving License :

No

Hazardous Material(s) :

No

Job Posting End Date :

11 / 14 / 2025

• 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.

Required Experience :

IC

Key Skills

CSS,Cloud Computing,Health Education,Actuary,Building Electrician

Employment Type : Full-Time

Experience : years

Vacancy : 1