Clincial Data Manager

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.  

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia 

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.  

We have nourished a true international culture here at Ergomed.  

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient's lives.  

The position is also available in any of our European locations

The Data Manager within the ERGOMED Data Management (DM) is responsible for database testing, query management, management of lab reference ranges, serious adverse event reconciliation, vendor data reconciliation and other tasks related to data management. The Data Manager represents a position under direction of the Manager, Data Management and is supervised by the Project Data Manager on a project level.

The Data Manager is responsible for supporting various data management activities from initiation of protocol through database lock data cleaning activities including:

Study start-up

• Perform validation of EDC Systems and associated DM reports or listings
• Perform validation of EDC and SAS edit checks
• Manage and Create EDC user accounts
• Update and maintain DM documentation as directed by the Lead Data Manager (LDM) or Project
• Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development

Study Conduct (Support multiple moderate complexity / complex trials with minimal supervision)

• May enter Data from trial documents into data entry system
• May perform Medical Coding
• Manage the entry, review, and tracking of Local/Central Lab reference ranges
• Attend internal/external teleconferences as needed
• May create and review study metric reports for internal/external project teams
• Notify management of roadblocks for getting processes done in a timely manner and offer possible solutions
• Provide the PDM with status updates on tasks that are assigned
• Escalates significant issues promptly to the study team

Study Closure

• Support the Lead Data Manager with all DM related close-out activities and DBL checklist (query resolution, final reconciliations, development of reports)

Bachelor's Degree, preferably in Live Sciences, Computer Science, or other related scientific discipline

• 2-5 years of relevant clinical data management experience in pharmaceutical industry and/or contract research organization and/or similar data management experience in a non-clinical environment

The position is also available in any of our European locations   

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

 We offer: 

• Training and career development opportunities internally  
• Strong emphasis on personal and professional growth 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join  

• Quality 
• Integrity & Trust  
• Drive & Passion  
• Agility & Responsiveness  
• Belonging 
• Collaborative Partnerships  

We look forward to welcoming your application. 

#LI Remote