Bioanalysis Manager Consultant

TFS HealthScience; Lunds kommun; On-site; SEK 700,000 - 1,100,000; Part time

Job summary

TFS HealthScience is seeking a Bioanalysis Manager Consultant to support an oncology-focused clinical development program. You will coordinate bioanalytical and central laboratory activities across studies, ensuring efficient sample management, vendor oversight, and study execution.

As part of our SRS/FSP team, you will work with one sponsor and external vendors in a global setting, contributing to protocol development and study documentation.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Biotechnology, Pharmacy, or a related field.
• Experience supporting bioanalysis, biosample management, biomarker programs, or central laboratory activities within clinical trials.
• Previous oncology clinical research experience preferred.
• Experience with external laboratories, CROs, or other clinical trial vendors.
• Good understanding of GCP and study documentation.

Responsibilities

• Prepare and review central laboratory proposals and vendor documentation.
• Author and review laboratory manuals, sample collection guidelines, and laboratory specifications.
• Coordinate sample shipments and outsourced bioanalytical activities with central laboratories and external vendors.
• Support biobank activities, including sample inventory management and documentation maintenance.
• Contribute to protocol development and study documentation, including informed consent forms and laboratory-related sections.
• Ensure appropriate filing, maintenance, and archiving of laboratory documentation.
• Act as a key point of contact between study teams, laboratories, and external service providers.
• Support biosample and biomarker management activities throughout the clinical trial lifecycle.

Skills

English fluency

Organizational skills

Education

Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Biotechnology, Pharmacy, or related field

Job description

About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions.

We are currently seeking a Bioanalysis Manager Consultant to support an oncology-focused clinical development program. In this role, you will be responsible for coordinating and overseeing bioanalytical and central laboratory activities across clinical studies, ensuring efficient sample management, vendor oversight, and study execution.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

Key Responsibilities

• Prepare and review central laboratory proposals and vendor documentation

• Author and review laboratory manuals, sample collection guidelines, and laboratory specifications

• Coordinate sample shipments and outsourced bioanalytical activities with central laboratories and external vendors

• Support biobank activities, including sample inventory management and documentation maintenance

• Contribute to protocol development and study documentation, including informed consent forms and laboratory-related sections

• Ensure appropriate filing, maintenance, and archiving of laboratory documentation

• Act as a key point of contact between study teams, laboratories, and external service providers

• Support biosample and biomarker management activities throughout the clinical trial lifecycle

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biomedical Sciences, Biotechnology, Pharmacy, or a related field

• Experience supporting bioanalysis, biosample management, biomarker programs, or central laboratory activities within clinical trials

• Previous experience in oncology clinical research is strongly preferred

• Experience working with external laboratories, CROs, or other clinical trial vendors

• Strong understanding of clinical trial processes, study documentation, and GCP

• Experience with biobanking and sample logistics is considered an advantage

• Excellent organizational and stakeholder management skills

• Fluent in English, both written and spoken

Assignment Details

• Initial 6-month consultant assignment

• Potential for extension

• 0.5 FTE

• Start date: October 2026

• Preference for on-site presence, though flexibility may be considered for the right candidate