Sr Clinical Data Manager

About Balt  

Our purpose is to improve the lives of 150,000 patients in 2026.  

 Our story 

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices.  Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting. 

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives. 

 Why Join Balt? Join a passionate team, dedicated to making a difference.  

1. Working at Balt means giving meaning to your work! Pride is a strong part of our identity.  
2. We are a close-knit team, with strong mission, vision and values that guide our day-to-day.  
3. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.  
4. No matter the country, we take care of you.  

Would you like to be part of our story? Don't hesitate, come and join us! 

 About this opportunity – Sr Clinical Data Manager

Description:

Provides clinical data management and displays a proactive approach to plan, prepare and execute the electronic data elements of one (or more) high quality clinical project(s).  Ensures deliverables are completed in a timely fashion within the agreed project timelines. Serves as primary interface with all study functions and acts as key liaison with electronic system vendors.

Job Responsibilities:

Responsible for all activities related to the support of clinical study data collection and deliverables:

• Knowledge of and ability to develop and document CDM processes and procedures per applicable US, EU, and international regulations (as applicable)
• Creation of CDM documents, including, but not limited to: Data Management Plan, CRF completion guidelines, EDC manuals
• Ability to support development of a new clinical database
• Independent development of database and edit checks specification for protocol-specific data collection
• Database validation
• Documents and leads UAT for the assigned study(ies)
• Generate and provide data reports to the study team
• Ongoing study data review/query management, reports generation

Qualification Requirements:

• Analytical - Ability to support structure of data collection to support analysis of diverse information
• Design - Generates creative solutions; demonstrates attention to detail
• Problem Solving - Gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations
• Adaptability & Dependability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events. Takes responsibility for own actions; keeps commitments.
• Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas
• Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence. Independently motivated.

Skills:

• Excellent verbal, written communication skills as well has have attention to detail.
• Ability to complete tasks with minimal oversight. Robust experience with EDCs, including Medidata.

Pre-requisites / Job Experience:

• Bachelor’s Degree required
• Minimum 5 years of related clinical trial experience
• Working knowledge of CFRs, IDE, PMA, GCPs and ICH Guidelines.
• Proficiency in Microsoft Office applications.
• Ability to work independently, prioritize and work within a matrix team environment is essential.

Physical Requirements:

• Extensive computer usage
• Extended periods of sitting
• 10-20% domestic/international travel

Work Environment:

May be remote with occasional requirements to travel to Balt and/or clinical research sites and/or conferences.  Working conditions are normal for an office environment.

The above information on this description have been designed to indicate the general nature of work performed by employees within this position. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities. tasks, and duties, and does not limit the assignment of additional duties for this position. 

Balt Group is an Equal Employment Opportunity employer.

More information please go to www.baltgroup.com 

Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases. 

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