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Job description
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.
This position is based at the Kaunas, Lithuania location. Hollister Incorporated is operating in a hybrid working environment.
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 GCAs data management SOPs and work instructions
Requirements
- 5-8 years of experience in medical device or pharmaceutical clinical research
- Minimum of 5 years of EDC Administration and Data Monitoring experience
- Bachelors 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
- 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.
Location
- Kaunas, Kauno apskritis, Lithuania
Time of work
- Full-time
Reda Maumevičienė
+37069571281
Alliance for Recruitment is the largest recruitment consultancy in Lithuania measured by capacity, number of successful placements and annual growth. We are a high performing team of recruitment experts from various different industries.
Our client – Hollister Lietuva is a part of Hollister Incorporated that is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide. They offer advanced medical products for Ostomy Care, which includes strong global brands – Hollister Ostomy and Dansac Ostomy; Continence Care; Critical Care; and Wound Care. They also provide innovative healthcare programs and services, as well as educational materials for patients and healthcare professionals. Hollister has been serving healthcare professionals and patients for 100 years making a difference in the journey of life for people throughout the global community.
The company is currently establishing a new Center of Excellence based in their facilities in Kaunas, Lithuania and assembling a team of accounting professionals.