

Healthcare
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.
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.
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.
Company
IQVIA
Location
Kuala Lumpur
Salary
Undisclosed
Skills Required
10 skills
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Clinical Research
Regulatory Compliance
Project Management
Good Communication
Negotiation
Organizational Skills
Interpersonal Skills
GCP/ICH Guidelines
Regulatory Documentation
Clinical Trial Management