Specialist Clinical Data Management

Padarome gyvenimą pilnavertiškesniu ir oresniu

Vieta: Kaunas 
Padalinys: 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:

• 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:

• 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:

3200-4300 Eur/mon. gross 

Apie „Hollister Incorporated“

„Hollister Incorporated“ yra nepriklausoma, darbuotojų valdoma įmonė, kurianti, gaminanti ir parduodanti sveikatos priežiūros produktus visame pasaulyje. Bendrovė investuoja į novatoriškų stomos priežiūros, šlapimo šalinimo sutrikimų ir kritinės priežiūros produktų pažangą, taip pat kuria mokomąją pagalbinę medžiagą pacientams ir sveikatos priežiūros specialistams. „Hollister“, kurios būstinė yra Libertyville mieste, Ilinojaus valstijoje, JAV, turi gamybos ir distribucijos centrus trijuose žemynuose ir vykdo pardavimus beveik 80 šalių. „Hollister“ yra „The Firm of John Dickinson Schneider, Inc.“ dukterinė įmonė ir vadovaujasi savo Misija – padėti žmonėms, naudojantiems mūsų gaminius ir paslaugas, gyventi oriau ir patogiau.

Mūsų Vizija - augti ir klestėti kaip nepriklausomai, darbuotojų valdomai įmonei, kartu tampant geresniais žmonėmis. Sužinokite daugiau www.Hollister.com.