Project Specialist

Job Title: Project Specialist

Reports to: Project Manager, Clinical Operations

Primary Objective of Position

The Project Specialist is responsible for providing operational support for the day-to-day execution of clinical trials' activities for European-based sites, following established SOPs, GCP and applicable regulatory requirements. The role includes facilitating central rater appointments, monitoring study-related activities, and collaborating across time zones to support global and regional project objectives. The specialist will proactively identify and resolve operational project issues and contribute to process improvement initiatives as required.

Major Duties/Responsibilities

· Coordinate the preparation, distribution, and maintenance of study-related documents, including those related to eCOA setup and data collection workflows.

· Facilitate the scheduling and monitoring of central rater appointments, ensuring timely completion and data accuracy.

· Serve as a liaison between study sites, central raters, and clients to troubleshoot issues related to the eCOA platform, such as technical challenges or data discrepancies.

· Track and monitor key study metrics, including participant compliance with eCOA requirements, central rater engagement, and site performance, escalating risks as necessary.

· Support the implementation of eCOA systems by assisting in system testing, user training, and deployment coordination.

· Prepare meeting agendas and minutes for internal and external meetings; may attend or lead meetings as directed by the Project Manager (PM).

· Maintain and monitor action items for projects, including following up on outstanding issues to ensure timely resolution.

· Collaborate with the PM to monitor study timelines and deliverables, ensuring alignment with regulatory requirements and project goals.

· Provide routine, ongoing status reports to clients and internal stakeholders, summarizing key metrics, risks, and operational updates.

· Ensure the proper archival of study documents, including data management reports, eCOA system logs, and project files, following regulatory and company guidelines.

· Support site monitoring activities related to data quality, compliance, and technical support for the eCOA platform.

· May act as the primary point of contact when the PM is unavailable, reporting directly to the Head of Clinical Development.

Skills and Abilities

· Strong understanding of data collection platforms, particularly eCOA systems, and their application in clinical trials.

· Clear and effective communication, both written and verbal, with technical and non-technical stakeholders.

· Ability to manage a moderate to high volume of tasks within tight deadlines while maintaining attention to detail.

· Strong organizational and prioritization skills, with the ability to handle multiple projects simultaneously.

· Team-oriented mindset with a demonstrated ability to collaborate across functional teams, study sites, and external partners.

· Proactive problem-solving skills, with the ability to identify and escalate operational issues effectively.

· Proficiency in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.), and familiarity with project management tools and electronic record-keeping systems.

Education and Professional Experience

· Bachelor's Degree (or equivalent) in life sciences or a related field, or equivalent combination of education and experience.

· Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable US regulatory requirements.

· Moderate relevant clinical research experience, including exposure to eCOA platforms and electronic data collection.

· Remote position with the possibility of travel if necessary (approximately 5-10%).

Job Type: Full-time

Pay: 70.124,00€ ,00€ per year

Application question(s):

• Do you have experience working with eCOA platforms or other electronic data collection systems in clinical trials? If yes, please briefly describe your experience.
• Have you previously worked in a role requiring cross-functional collaboration across different time zones? Please provide an example if applicable.

Work Location: Remote