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My client is a clinical stage biopharmaceutical company developing personalised T Cell therapies. They have developed an innovative approach to personalized oncology treatments with their first programs for Non-Small Cell Lung Cancer and Melanoma in clinic. If you want to be a part of a well-funded, exciting new start-up, and enjoy playing an active role in supporting the development and clinical manufacture of ATMPs, then this is the role for you.
Overview:
You will support regional or global Supply Chain Operations, in managing various administrative tasks and offering support across multiple Supply Chain Work streams such as implementation and validation support, reconciliation of records, meeting planning and generation of agenda’s and minutes, maintaining study tracking, filing and quality reviews, adhering to integrity and compliance with all applicable global and regional guidelines and regulations, ICH-GCP guidelines and SOPs.
Responsibilities:
• Provide general administrative support to the Supply Chain Operations Department
• Support with delivery of electronic systems being implemented across the department including validation and implementation coordination
• Familiar with various roles within clinical and Supply Chain operations, such as a CRA role and PM.
• Assist project teams with study specific documentation and guidelines as appropriate.
• Set up, organize and maintain Supply Chain specific clinical study documentation (e.g. registration forms, traceability documentation, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
• Assist in quality control audits of Supply Chain specific clinical study documentation (e.g. registration forms, traceability documentation, CRFs, etc.)
• Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
• Assist in co-ordination of vendor payments, if applicable.
• Maintain the Training Matrix and training forms.
• Conduct initial submission QC in Veeva Vault and assist in completing quarterly QC of the eTMF.
• Complete study metric trackers and reports.
Qualifications/Experience required:
• Experience as a CTA/Admin role in either pharmaceutical/biotech
• Expertise in Veeva
• Experience in clinical study execution
• Experience in cell therapy or oncology studies an advantage
This is a 12 month fixed term opportunity. The role will be predominantly office based in Hammersmith.
Expired
- Location: Hammersmith, W6 8PW
- Salary: £TBD plus generous benefits
- Job Type:Permanent
Posted almost 3 years ago
- Sector: Commercial Operations, Clinical Operations
- Contact: Alex Butcher
- Contact Email: alex.butcher@nextphaserecruitment.com
- Contact Phone: 01403 216216
- Start Date: 2021-07-01
- Job Ref: V-46893
Overview:
You will support regional or global Supply Chain Operations, in managing various administrative tasks and offering support across multiple Supply Chain Work streams such as implementation and validation support, reconciliation of records, meeting planning and generation of agenda’s and minutes, maintaining study tracking, filing and quality reviews, adhering to integrity and compliance with all applicable global and regional guidelines and regulations, ICH-GCP guidelines and SOPs.
Responsibilities:
• Provide general administrative support to the Supply Chain Operations Department
• Support with delivery of electronic systems being implemented across the department including validation and implementation coordination
• Familiar with various roles within clinical and Supply Chain operations, such as a CRA role and PM.
• Assist project teams with study specific documentation and guidelines as appropriate.
• Set up, organize and maintain Supply Chain specific clinical study documentation (e.g. registration forms, traceability documentation, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
• Assist in quality control audits of Supply Chain specific clinical study documentation (e.g. registration forms, traceability documentation, CRFs, etc.)
• Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
• Assist in co-ordination of vendor payments, if applicable.
• Maintain the Training Matrix and training forms.
• Conduct initial submission QC in Veeva Vault and assist in completing quarterly QC of the eTMF.
• Complete study metric trackers and reports.
Qualifications/Experience required:
• Experience as a CTA/Admin role in either pharmaceutical/biotech
• Expertise in Veeva
• Experience in clinical study execution
• Experience in cell therapy or oncology studies an advantage
This is a 12 month fixed term opportunity. The role will be predominantly office based in Hammersmith.