Site Activation Specialist I

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

📋 Description

• Oversee the Investigator Initiation Package, Investigational Product Release Form, and Activation Greenlight Form through the approval process, adhering to sponsor guidelines and quality standards.

• Manage regulatory documentation such as CVs, FDF, FDA 1572, and GCP training records.

• Pre-fill and circulate essential documents to sites.

• Review and conduct quality control on completed documents to ensure consistency.

• Compile study startup packages containing up to 40 documents per site for approval, enabling sites to receive study drugs and commence screening.

• Lead and collaborate on activities involving local and central Institutional Review Boards, Institutional Ethics Committees, and Central Ethics Committees for the relevant countries.

• Address inquiries from ethics and regulatory authorities.

• Manage protocol amendments and updates to essential documents throughout the study lifecycle.

• Engage with sites and site personnel to ensure completion of study documents at the required quality level.

⛳️ Requirements

• Possess a strong analytical and investigative mindset, capable of reviewing information from various sources to identify potential risks.

• Exhibit excellent attention to detail and a commitment to maintaining accuracy in documentation and data entry.

• Demonstrate sound professional judgment, with the ability to differentiate between factual findings, noteworthy items, and significant or disqualifying findings.

• Follow established processes while recognizing when escalation is necessary.

• Possess strong organizational and time management skills to handle competing priorities and meet deadlines.

• Exhibit clear written communication skills, including the ability to document rationale, evidence, and outcomes concisely and traceably.

• Comfortable with repetitive tasks and structured processes.

• Capable of maintaining quality and focus while performing similar assessments repeatedly.

• Equivalent experience, skills, and/or education may also be considered.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Fostering an inclusive culture.

• Provision of reasonable accommodations when appropriate.