FSP Senior Bioanalytical Study Manager
FSP Senior Bioanalytical Study Manager
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1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Senior Bioanalytical Study Manager
Role Overview:
Join our dynamic team and lead the charge in supporting AstraZenecas Development pipeline from a bioanalytical perspective. Youll manage bioanalytical operations for preclinical studies and clinical trials ensuring timely delivery of quality data by coordinating activities between multiple stakeholders.
Key Responsibilities:
- Vendor Management: Lead the contracting with thirdparty lab service providers for assay development and validation. Collaborate with business operations procurement and clinical teams to ensure appropriate SOWs and contracts.
- Study Coordination: Manage critical reagent supply and sample analysis. Work closely with bioanalytical strategy leads clinical trial teams and lab service providers to finalize study documents and meet timelines. Support the development of novel Bioanalytical processes.
- Documentation & Data: Provide input into clinical trial documents (e.g. eCRFs ICFs SOWs). Drive the delivery of data transfer specifications and ensure data accuracy.
- Sample Logistics: Track and reconcile sample testing resolving any issues that arise. Contribute to cleaning and finalizing data.
Qualifications:
- Education: BA/BS or higher in medical science or a related field plus 4 years (BA/BS) or 2 years (MS) of clinical trial management experience.
- Experience:
- Familiarity with clinical bioanalysis outsourcing operations.
- Knowledge of GLP GCP guidelines and vendor audits.
- Understanding of clinical trial design and data outputs.
- Experience with sample collection instructions and lab manuals.
- Proficiency in data transfer agreements/specifications and data reconciliation.
- Skills:
- Strong organizational and analytical skills.
- Excellent written/verbal communication.
- Ability to work both independently and as part of a team.
- Proficiency with Excel and other interactive programs.
Why Join Us
- Innovative Environment: Work on cuttingedge projects in a collaborative setting.
- Professional Growth: Opportunities for learning and development.
- Impactful Work: Contribute to lifechanging clinical trials and research.
Apply Now and Make a Difference in Bioanalysis!
Required Experience:
Manager
Employment Type
Full-Time
