Senior Bioanalytical Study Lead for Late-Phase Trials

ThermoFisher Scientific; Sweden; Remote; SEK 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Healthcare

Annual bonus plan

Competitive remuneration

Job summary

Thermo Fisher Scientific seeks a Senior Bioanalytical Study Manager to oversee bioanalytical operations for pre-clinical studies and clinical trials, coordinating across multiple internal and external stakeholders to ensure timely delivery of high-quality data.

The role emphasizes late-phase studies, LC-MS and ligand-binding assays, regulatory awareness, and collaboration with vendors, CROs and clinical teams to drive study documentation and data transfer.

Qualifications

• BA/BS in a scientific discipline and at least 2 years of project or study management in a bioanalytical setting.
• Experience in regulated bioanalytical, pharmaceutical or clinical development environments.

Responsibilities

• Vendor management: support contracts with external labs for assay development and analysis.
• Study coordination: manage bioanalytical activities across clinical studies and timelines.
• Bioanalytical oversight: coordinate LC-MS and LBA platforms for small- and large-molecule work.
• Late-phase development: support high-priority late-phase studies and regulatory alignment.
• Regulatory support: ensure activities meet regulatory expectations and requirements.
• Documentation & data: contribute to eCRFs, ICFs and SOWs with data transfer specs.
• Sample logistics: track samples and testing to avoid delays.
• Biomarker activities: support biomarker bioanalysis across teams and labs.

Skills

Organizational skills

Project management

Analytical skills

Written & verbal communication

Stakeholder management

Vendor management

Cross-functional collaboration

Attention to quality & timelines

Regulatory awareness

Excel proficiency

Education

BA/BS in a scientific discipline

Tools

LC-MS

LBA

Job description

Thermo Fisher Scientific seeks a Senior Bioanalytical Study Manager to oversee bioanalytical operations for pre-clinical studies and clinical trials, coordinating across multiple internal and external stakeholders to ensure timely delivery of high-quality data.

The role emphasizes late-phase studies, LC-MS and ligand-binding assays, regulatory awareness, and collaboration with vendors, CROs and clinical teams to drive study documentation and data transfer.