Site Activation Partner I

This is a fully remote position, open to applicants in Australia.

📋 Description

• Initiate and oversee activities related to clinical trial site activation and manage essential documents through the compilation of the Investigator Initiation Package and site initiation approval.

• Prepare, validate, and submit regulatory documents while providing support for internal regulatory approval processes.

• Coordinate various support roles, manage ethics committee submissions, and oversee investigator site workflows and study approval activities.

• Manage clinical documentation, reports, and activities within the Shared Investigator Platform.

• Oversee documentation and updates related to study conduct, including protocol amendments, revisions of FDA 1572/Attestation, and approvals from ethics committees.

• Maintain activities with the IRB/Ethics Committee and file documents in the Trial Master File.

• Conduct periodic quality reviews of study files to ensure accuracy and completeness.

• Update clinical trial systems to track site compliance and performance effectively.

• Assist investigator sites and study teams with responses to audits and inspections.

• Maintain communication with study teams, investigator sites, clients, and stakeholders.

• Provide updates at the country and site level regarding site status, issues, delays, and approvals.

• Support awareness sessions for site personnel and ensure ongoing compliance with study documentation, applicable laws, GCP, and client standards.

• Identify and resolve issues at investigator sites and coordinate corrective and preventive actions.

• Act as a point of contact, subject matter expert, or representative for Site Activation Partner initiatives as assigned.

• Assist in mentoring new hires on relevant processes and systems.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Adhere to Parexel processes, ICH-GCPs, and other relevant requirements.

⛳️ Requirements

• Comprehensive knowledge of clinical research and development processes, along with key operational elements of clinical trials.

• Ability to comprehend detailed processes and quality expectations.

• Compliance with applicable company policies, regulatory standards, and country-specific requirements.

• Strong attention to detail and a disciplined approach.

• Capacity to work independently as well as collaboratively within a team.

• Skills in organizing tasks, managing time and priorities, and multitasking.

• Basic understanding of medical terminology.

• Familiarity with Good Clinical Practice (GCP) requirements.

• Proficient in computer operations with the ability to learn and independently utilize multiple systems.

• Experience with Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Trial Master File, Electronic Investigator Site File, document exchange portals, Shared Investigator Platform, and ethics/governing-body portals as needed.

• Flexibility to work outside standard hours in a global environment when necessary.

• Willingness to travel as needed, including potential international travel.

• Preferred experience in the pharmaceutical industry or CRO study site activation.

• Understanding of clinical trial methodologies, ICH/GCP, FDA regulations, and local and global country regulations.

• Required fluency in the local language and English; multilingual capabilities are preferred.

• Strong verbal and written communication skills.

• Good technical proficiency and the ability to learn and operate multiple systems.

• Educational background of a school diploma or certificate with a suitable combination of education, training, and experience, or a Bachelor of Science/Bachelor of Arts or equivalent.

• Preferred education in life sciences.

• Minimum of 2 years of relevant experience in clinical site management.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career growth.

• Collaborative and supportive team environment.

• Flexible work arrangements to promote work-life balance.