EDC Data Solution Specialist

We are looking for an EDC Data Solution Specialist who is ready to take ownership of high-impact projects. At our core, we value delivery over slides and results over rigid hierarchy.

Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical companies, as well as Contract Research Organizations (CROs) that outsource clinical trial management.

If you have a deep background in eClinical solutions and want to transition from being a cog in the machine to a key driver of product and process, we want to talk to you.

You will lead complex system implementations from pre-sales through to go-live: consulting with clients, navigating complex data migrations, and ensuring our product scales within large life sciences organizations.

What You'll Do

• Develop, configure, and test study databases in the EDC system.
• Create and maintain study-specific plans, including database specifications and validation guidelines.
• Assist customers with study-specific EDC system configuration (electronic case report forms (eCRFs), IRT, etc.).
• Program automated edit checks; review and resolve data discrepancies and deficiencies, including query generation and closure.
• Import, verify, and reconcile laboratory and external safety data (e.g., SAE data).
• Prepare and present study datasets as required.
• Coordinate study database lock/unlock, data exports, and archiving.
• Host and support internal and external audits relevant to the EDC function.
• Draft and update guidelines, procedures, templates, and related documentation within the EDC Unit.
• Provide training and mentoring.
• Deliver training on EDC usage and clinical data flows.
• Act as a subject matter expert for the Helpdesk, handling requests related to the EDC system and data solutions.

Who You Are

• Solid understanding of clinical data processes, supported by relevant training.
• Minimum of 2 years of experience working with EDC systems and clinical trial data workflows.
• Advanced English proficiency.

Job Conditions

• Flexible work schedule.
• Fully remote work.
• Annual leave (depending on contract type).
• Sick days fully paid by the company (depending on contract type).
• Competitive compensation based on experience and skills.
• A team of highly qualified professionals.
• Open-door policy and low bureaucracy.

How We Work

• Flexibility and results: We care more about what you achieve than the exact hours you work. We offer flexible start times between 8:00 and 11:00. Participation in client meetings and scheduled team meetings is important.
• Respect and transparency: We value respect, transparency, proactivity, openness, and a positive approach. We care about our team’s mental health and well-being, maintain an open-door policy, and welcome constructive feedback from both sides.
• Teamwork and long-term relationships: We believe in working collaboratively with our clients and colleagues to build lasting, trusted relationships.

How to Apply

To apply for this position, please use Linkedin or send you CV via hr_team@flexdatabases.com.

Rad na daljinu: Da

Izvor: https://www.linkedin.com/jobs/view/4470165428/

Nivo: senior