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Site Activation Specialist (6 – IQVIA

IQVIA
Kuala Lumpur
Salary: Undisclosed
IQVIA

IQVIA

Healthcare

Role Summary

The Site Activation Specialist role is a 6-month contract position responsible for acting as a Single Point of Contact for assigned studies involving investigative sites. The role involves collaboration with various teams and ensuring compliance with regulations, company standards, and project timelines in support of clinical research activities.

Job Description

The role serves as a Single Point of Contact (SPOC) for assigned studies involving investigative sites and collaborates with teams such as RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership, and GICS. Responsibilities include ensuring adherence to SOPs, work instructions, quality deliverables, and project timelines, as well as potentially acting as a Country Lead in the absence of a regional Lead. This position encompasses performing Regulatory, Start-up, and Maintenance activities per applicable regulations and company standards, preparing and reviewing regulatory documents, contracts, and budgets, maintaining databases and tracking tools, monitoring site performance, supporting project planning and timelines, and providing input or support in various other functions such as regulatory intelligence collection, pre-award activities, contract and budget template development, importation activities, sponsor communications, mentorship, training delivery, feasibility, site identification, and site selection visits if qualified.

Job Requirements

Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.

In-depth knowledge of clinical systems, procedures, and corporate standards.

Good negotiating and communication skills with ability to challenge, if applicable.

Effective communication, organizational, and interpersonal skills.

Ability to work independently and to effectively prioritize tasks.

Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.

Understanding of regulated clinical trial environment and knowledge of drug development process.

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Quick Info

Company

IQVIA

Location

Kuala Lumpur

Salary

Undisclosed

Skills Required

10 skills

Click to submit your application

Required Skills

1

Clinical Research

2

Regulatory Compliance

3

Project Management

4

Good Communication

5

Negotiation

6

Organizational Skills

7

Interpersonal Skills

8

GCP/ICH Guidelines

9

Regulatory Documentation

10

Clinical Trial Management

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