Senior Bioanalytical Study Lead (Preclinical & Clinical)

Regulatory Jobs; North Carolina; On-site; USD 100,000 - 150,000; Full time

Job summary

Thermo Fisher Scientific seeks a Senior Project Manager to lead bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data. You will coordinate with multi-disciplinary teams to drive study execution, data integrity, and process improvements across LC-MS workflows and analytical platforms.

You will oversee vendor contracts, document development, sample logistics, and data transfer specifications, working in a collaborative, fast-paced

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 5+ years of experience or equivalent combination of education, training, & experience in bioanalytical/project management.

Responsibilities

• Vendor management: lead contracting with third-party lab service providers for assay development and validation.
• Study coordination: manage critical reagent supply and sample analysis with cross-functional teams to meet timelines.
• Documentation & Data: contribute to clinical trial documents (eCRFs, ICFs, SOWs) and data transfer specifications, ensure data accuracy.
• Sample logistics: track testing, reconcile results, and support data cleaning and finalization.

Skills

Vendor management

Cross-functional collaboration

Data analysis

Excel proficiency

Education

Bachelor's degree or equivalent

Tools

SOPs

Job description

Thermo Fisher Scientific seeks a Senior Project Manager to lead bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data. You will coordinate with multi-disciplinary teams to drive study execution, data integrity, and process improvements across LC-MS workflows and analytical platforms.

You will oversee vendor contracts, document development, sample logistics, and data transfer specifications, working in a collaborative, fast-paced