Trial Data Manager
- Employer
- Warman O’Brien
- Location
- Basel, Canton of Basel-Stadt (CH)
- Salary
- Competitive hourly rate
- Start date
- 13 Jul 2022
- Closing date
- 12 Aug 2022
View more
- Discipline
- Data Management / Statistics, Clinical Data Management
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
A Trial Data Manager is required to join a global pharmaceutical company based in Basel on an initial 12 month contract.
Main responsibilities will include:
- Ensures that Data Management activities standards, and applicable regulations
- Meets study timelines in terms of Data Management deliverables
- Ensures data handling consistency within allocated study(ies)
- Leads Data Management activities for assigned study
- Provides Data Management input to the development of the study protocol
- Coordinates the development of the (e)CRF in line with company standards
- Writes all study Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to Data Management Programmer(s) for development for the allocated study(ies)
- Organizes, monitors and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environment
- Organizes, monitors and tracks data cleaning, data review, query management, and database lock. Makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders
- Generates study metrics and status reports
- Represents Data Management at Clinical Trial Team (CTT) meetings
- Manages and is accountable for Data Management activities in studies where Data Management is outsourced
- Ensures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, define.xml and annotated CRF) are created, validated and provided as per agreed timelines
- Performs and/or coordinates Quality Control (QC)
Candidate Specifics:
- Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines
- At least 3 years’ experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical Data Management with good level of functional expertise in Data Management
- Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization – Good Clinical Practice (ICH/GCP)
- Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design
- Ability to lead and coordinate the activity of Data Manager(s) allocated to his/her study
- Good organizational and presentation skills
- Fluent in written and spoken English
This role will be full-time office based, is paying a competitive hourly rate and is open to all candidates who are EU/EFTA Citizens or hold valid Swiss work Permits.
Company
Warman O’Brien is a global specialist Life Sciences Recruitment Partner across the UK, Europe, USA and APAC. We recruit top talent across a number of functional areas including:
- Biometrics
- Data Sciences
- Quality Assurance
- Regulatory Affairs
- Clinical Research
- Discovery Sciences
- C-Suite
- Medical Affairs
We cover contract and permanent vacancies, executive search, and SOW for companies across the pharmaceutical industry.
Find out more on our website warmanobrien.com/
- Website
- https://warmanobrien.com/
- Telephone
- +44 (0) 2033255075
- Location
-
Floor 5
Regal House
70 LONDON ROAD
Twickenham
TW1 3QS
United Kingdom
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