EMA Wellness is dedicated to advancing clinical research through innovative, real‑time digital data collection solutions. We’re seeking a Project Specialist who will play a key role in supporting day‑to‑day study operations, coordinating stakeholders, and ensuring high‑quality execution across clinical trial activities. If you’re detail‑oriented, tech‑savvy, and thrive in a fast‑paced, collaborative environment, this is an opportunity to contribute to meaningful improvements in patient‑centric research.
Job Description:
As a Project Specialist at EMA Wellness, you will support the operational execution of clinical trials for U.S.‑based sites, working closely with Project Managers, central raters, clients, and study teams to keep projects running smoothly and efficiently. You will coordinate the preparation and maintenance of essential documents, monitor study workflows, schedule central rater appointments, and help ensure high data quality across eCOA platforms. This role also involves troubleshooting technical and operational issues, tracking study metrics, preparing meeting materials, and contributing to project timelines and deliverables.
A key part of your responsibilities will include supporting the implementation and maintenance of eCOA systems, assisting with user trainings, participating in system testing, and collaborating cross‑functionally to resolve emerging challenges. You may also serve as a point of contact in the Project Manager’s absence, providing continuity and maintaining communication across teams and time zones. With exposure to both operational and technical aspects of clinical research, this role offers a dynamic, hands‑on environment where no two days look the same.
The ideal candidate is highly organized, adaptable, and proactive, with a strong ability to manage multiple tasks while maintaining accuracy and attention to detail. They excel in communication—both written and verbal—and can comfortably engage with technical and non‑technical stakeholders. A successful candidate thrives in collaborative settings, brings strong problem‑solving skills, and is motivated by the opportunity to support digital innovation in clinical trials. A solid understanding of GCP, ICH guidelines, and eCOA systems will help the Project Specialist make an immediate impact.
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%).
