Junior Data Manager

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description

ROLE

The Data Manager role involves the following points:

• Ensure DM tasks for the assigned studies are performed on time and within budget  

• Contribute to develop the data collection specification from all data sources  

• Manage in-stream data flow activities and deliver a quality database in accordance with the project plan and with the supervision of senior staff  

KEY RESPONSABILITIES 

• Accountable for achieving project milestones from study start up through to delivery of database and monitoring of time spent of tasks

• Design the Case Record Form and guide process for CRF approval 

• Define and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team 

• For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF

• For EDC studies, timely response to issues identified by the eCRF Helpdesk  

• Prepare CRF completion guidelines  

• Prepare study specific data-entry guidelines and train data-entry staff  

• Perform term coding for clinical studies, raise manual queries for uncoded terms as required  

• Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual check and Medical Review listings  

• Apply SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activities generating all the required documentation for study files  

• Prepare study specific data-entry guidelines and train data-entry staff  

• Input into and monitor progress against study project plan and escalate issues for resolution at the appropriate level  

• Run and monitor study data progress reports including query management and take appropriate actions (e.g. escalation, re-training, etc), escalate any study issues within study team  

• Perform timely data integration of CRF and non CRF data (data import from external sources)  

• Perform reconciliation of external data (e.g. SAE, Central Labs, ECGs, etc)  

• Define and execute QC plan, lead and execute database release and database freeze/lock activities  

• Plan and prioritise his/her own work and take appropriate actions (e.g. escalate)  

• Conducts other activities as required  

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DESIRED QUALIFICATION & EXPERIENCE 

• Degree in life science, pharmaceutical, biology or related field or at least 6 months experience in data management field or similar in a pharmaceutical environment or equivalent 

• Basic understanding of pharmaceutical industry guidelines like ICH, GCP etc  

• Basic understanding of Data Management processes  

TECHNICAL COMPETENCES & SOFT SKILLS 

• English, Fair

• MS Office Suite, Good

• Professional   

• Trustworthy  

• Ability to effectively prioritize  

• Quality focused  

• Personable Attitude  

• Willingness to learn  

• Team Player  

Contract Type