Site Activation Specialist 1

IQVIA Argentina; Daerah Khusus Ibukota Jakarta; On-site; IDR 100,000,000 - 200,000,000; Full time

Job summary

An established industry player is seeking a detail-oriented individual to serve as a Single Point of Contact for site activation in clinical studies. This role involves preparing and reviewing essential documents, ensuring compliance with regulatory standards, and maintaining effective communication with team members and investigative sites. The ideal candidate will have a Bachelor's degree in Life Sciences and 1-2 years of relevant experience, showcasing strong organizational and interpersonal skills. Join a dynamic team where your contributions will support the advancement of clinical research and drug development processes in a collaborative environment.

Qualifications

• 1-2 years of clinical research experience or equivalent education.
• Knowledge of GCP/ICH and regulatory guidelines.

Responsibilities

• Serve as a Single Point of Contact for site activation activities.
• Prepare and review site documents for completeness and accuracy.

Skills

Regulatory Submission

Negotiation Skills

Communication Skills

Organizational Skills

Interpersonal Skills

Ability to Work Independently

Education

Bachelor's Degree in Life Sciences

Job description

Essential Functions:
• With moderate oversight and supervision, serve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory contractual and other documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Requirements:
• Bachelor's Degree in Life Sciences or a related field.
• 1 - 2 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
• Experienced in regulatory submission.
• 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.