Biospecimen Specialist (m/w/d)
Biospecimen Specialist (m/f/d)–LIMS/GMP / Stakeholder Management / Data Management / English**
Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Biospecimen Specialist (m/f/d)
Background:
The Biospecimen Acquisition & Management team (BAM) team at Roche Diagnostics International (RDI) leads the acquisition and management of biological materials and clinical samples with associated data designed to facilitate and advance local R&D activities. BAM collaborates with various Life Cycle Teams, Projects, and Functional Areas to ensure that customer requirements for biological materials are agreed to, via formal established processes, communicated to on a periodic basis, and met per commitment in compliance with Good Laboratory Practices, Good Clinical Data Management Practices, Quality, and Business standards.
The Biospecimen Specialist (SE4) is responsible for all associated sample/test data in compliance with local regulatory requirements, quality, business, and industry best practices/standards within Roche Diagnostic Solutions (RDS).
Tasks & Responsibilities:
Conducts data management activities, such as, supplier file creation, data file transfers from suppliers and tracking of source data files.
Executes data review, transcription, import, data quality and consistency checks, data searches, resolution of data discrepancies, and data export while working within a validated LIMS.
Assumes accountability for data entry into validated database(s), ensures that information is entered accurately and consistently, and according to established formats.
Supports the testing of change cycles of LIMS databases.
Future possibility to support acquisition of biospecimens including; gathers requirements, facilitates purchase requisitions and partners with external vendors to acquire basic biological materials to ensure flexible and successful delivery
Must Haves:
- Bachelor’s degree in Science
- Proficient with MS Excel and Google suite
- Prior data management experience in the diagnostics, pharmaceutical or medical device industry preferred.
- Fluent English min. C1 Level
- Self-motivated and solution driven individual who can maintain quality, accuracy and timeliness of deliverables.
- Excellent interpersonal skills and stakeholder management.
- Good organizational, written and verbal communication skills.
- Team player, self organized and motivated individual.
- Meticulous attention to detail
- Ability to work in a fast paced, dynamic environment with efficiency; and capable of handling multiple projects.
- Ability to follow oral and written instructions.
Nice to have:
- Understanding of regulatory requirements related to diagnostics
- German
Reference Nr.: 923126TP
Role: Biospecimen Specialist (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 100%
Start: 01.02.24
Duration: 12++
Deadline : 10.01.2024
Kontaktperson:
Roche Pharma AG HR Team