Specialist Clinical Data Management

Location:

(LT-54462) Kaunas, Lithuania

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Finance, Banking & Insurance Jobs

Other Industries & Skills: 

Education & Training Information Technology, Legal

Advertiser:

Hollister Incorporated

Job ID:

130722944

Posted On: 

27 June 2024

We Make Life More Rewarding and Dignified 

Location: Kaunas 
Department: Clinical Affairs 

The Specialist, Clinical Data Management (CDM) is a leader in supporting
clinical studies for
Hollister Incorporated medical device products and services. The CDM
leads all aspects of clinical data management from study planning to database lock including EDC design, data review/cleaning, query management, data reconciliation, and data transfer. The CDM regularly collaborates with Global Clinical Affairs (GCA) study team members (Clinical Project Management, Biostatistics, Clinical Operations, Clinical Scientist) and cross-functional departments
to ensure high data quality. The position operates under minimal supervision and independently evaluates, selects, and applies data management practices to a variety of research projects.

Responsibilities:

-Lead the development of data management sections of clinical protocols and Case Report Forms
-Develop and maintain essential documentation for the Trial Master File, ensuring regulatory compliance
-Support clinical studies by aligning data management plans, questionnaire development, and data handling activities with study objectives
-Design and build clinical study databases in EDC Systems, including edit checks, data dictionaries, and queries/alerts
-Lead User Acceptance Testing (UAT) for database validation
-Train clinical research personnel on study-specific CRF, EDC, and other project-related items
-Oversee data management vendor relationships, including EDC partners and CROs
-Continuously enhance EDC systems to improve efficiency and data quality
-Monitor and query clinical data to resolve discrepancies according to Clinical Protocol and/or Data Management Plan
-Coordinate AE/DD reconciliation
-Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and internal SOPs
-Contribute to the development of GCA’s data management SOPs and work instructions

Requirements:

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-5-8 years of experience in medical device or pharmaceutical clinical research
-Minimum of 5 years of EDC Administration and Data Monitoring experience
-Bachelor’s degree in life sciences, computer science, or a related field
-Certified Clinical Data Manager (CCDM) preferred
-Proficiency in questionnaire development, database structure, and data management processes
-Experience with EDC Systems (e.g., Medrio, Medidata Rave)
-Understanding of clinical research regulations
-Experience with data visualization tools (PowerBI, Tableau) is a plus
-Ability to work independently and as part of a multifunctional team
-Proficiency in English and Lithuanian

Company Offers:

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-Learning and development-oriented culture
-Annual bonus based on personal performance
-Additional bonus based on company performance
-A benefits package, including health insurance, to support your well-being
-Flexible working hours
-Fresh and healthy breakfast and lunch at our site’s restaurant, available at an exclusive company price
-Team-building, summer festivals, and special events
-Associate well-being program – free professional consultations with psychology, law, and finance specialists
-Free charging stations for electric cars
-24/7 accident insurance.
We guarantee confidentiality and will inform only selected candidates.

Salary:

# Eur/mon. gross 

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings. 
 

 Hollister is an EO employer – M/F/Veteran/Disability
Job Req ID: 33169

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