Site Activation Specialist I

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

📋 Description

• Assist with site and investigator evaluation processes.

• Gather, review, and analyze regulatory, compliance, quality, and performance data.

• Aid in site selection, study initiation, and ongoing study management.

• Identify possible risks and raise any concerns.

• Work alongside internal stakeholders to ensure prompt resolution of issues.

• Follow project guidance from the assigned country start-up advisor and Site Activation Manager.

• Assemble and/or review essential document packages necessary for site activation.

• Gather essential documents from study sites.

• Prepare and submit applications to central and local ethics committees, regulatory authorities, and other local approvals under supervision.

• Prepare ongoing submissions, amendments, periodic updates, and safety notifications as needed.

• Act as a liaison between investigational sites and functional leads.

• Manage the overall site activation process at both the country and site levels.

• Assist in site selection based on the requirements of clinical trials.

• Help with country-template and site-specific contracts and budgeting.

• Support contract and budget negotiations under supervision.

• Aid in quality control, execution of clinical trial agreements, document archiving, and metadata collection.

⛳️ Requirements

• Strong analytical and investigative mindset.

• Ability to review information from various sources and identify potential risks.

• Exceptional attention to detail.

• Commitment to accuracy in documentation and data entry.

• Sound professional judgment.

• Capable of distinguishing factual findings, noteworthy items, and potential significant or disqualifying issues.

• Ability to adhere to established processes and recognize when escalation is necessary.

• Strong organizational and time management abilities.

• Competent in managing competing priorities and meeting deadlines.

• Clear and effective written communication skills.

• Ability to document rationale, evidence, and outcomes in a concise and traceable manner.

• Comfortable with repetitive tasks and structured processes.

• Ability to maintain quality and focus while conducting similar assessments repeatedly.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Comprehensive total rewards program.

• Inclusive company culture.

• Reasonable accommodations when appropriate.