Clinical Data Administrator
Based Ware , Herts
Full time
Onsite role some WFH
Contract role 6 months to 1 year
Our client is a world leading research-based pharmaceutical company renowned for pushing the boundaries of medical innovation are seeking an experienced Clinical Data Administrator to provide high quality support for their site.
Job Purpose:
The role exists to support the team responsible for Clinical Trial label creation and approval activities within existing GMP computer systems. The role will comprise of executing GMP activities related to Clinical Study Data Entry and Approval with a keen focus on right first time and delivery to defined supply chain lead-times and collation of key metrics for the label creation process. The role will require the ability to work across several departments to ensure business requirements are met.
In addition, the role includes responsibility for ensuring clinical supplies are packed and labelled using optimum components, by managing, administering and delivering Packaging Assessment Request Forms (PARF) and ensuring that concise instructions for how those components are put together and are clearly documented in the Master Packaging Specification (MPS) document for use by the Packaging Operations teams.
The role will have accountability for creating and approving packaging components specifications, physically maintaining the Ware site sample studio and creating and approving pack family documents.
It is expected that the job will also play a leading role to build in quality for the patient at the earliest possible stage.
- Effectively execute pre-label creation activities to enable accuracy and compliance of GMP Data within Global Packaging Operations.
- Providing support within Global Packaging Operations teams in all aspects related to Clinical Trial pack and label approval.
- To seek and support internal and wider process improvement opportunities in conjunction with key supply chain business partners.
Key Responsibilities:
- To ensure Data Entry is accurate and completed within appropriate timelines and GMP equirements.
- Responsible for creating and approving data linked to Clinical Labels
- Ability to use relevant computer packages, e.g. Excel, Word
- Multi-skills expected, i.e. able to work within other areas when required
- Complies with appropriate Standard Operating Procedures to ensure accuracy for the GMP activities being conducted.
- Understand process across the supply chain in order to ensure timely and accurate delivery of both information and documentation to the next node in the supply chain
- Look for opportunities to develop and improve existing processes relating to Data Entry for Label Creation activities and the PARF & MPS processes.
- Monthly Collation and Reporting of of key metrics for the Label Creation Process.
- Involved in the process of developing packaging components to meet current industry and country specific requirements for the Clinical Trial Regulatory functions.
- Accountable for managing, administering and delivering Packaging Assessment Request Forms (PARF) and Master Packaging Specification (MPS) for Pack Family and Pack Component Board components.
- Execution & Assessment of Label Adhesion Testing
- Maintain & administer Pack Families.
- Maintain local sample studio, based at the Ware GSK site including Management Monitoring activities.
- Act as point of contact for packaging component, PARF and MPS queries.
Competencies: Include breadth & depth across disciplines or functions; behaviours and expertise in field
Skills needed -
- Strong oral & written communication skills
- Demonstrated computer skills in Microsoft office suite of products
- Good attention to detail.
- Demonstrates an understanding of clinical packaging and manufacturing terminology.
- Knowledge of Good Manufacturing Practices (GMPs) preferential
- Able to manage own time and workload priorities, self motivated and be able to work as part of a
team.
- Ability to Identify problems as they occur and beings them to the attention of the Team Leader.
- Demonstrate ability to set and reach goals, high standards of performance and ability to resolve
difficulties.
- Works effectively with others to meet timelines, business goals and objectives.
- Ability to work across different departments to deliver desired outcome to the wider business.
If you are interested and feel you have the right skills then please apply to this role.
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.
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