Study Manager

Study Manager

Location: Cambridge, England, United Kingdom (On-site)

About the Company

A leading contract research organisation is looking for a skilled scientist or study coordinator to step into the role of study manager and support in the delivery of client drug development studies.The study manager will be someone with good organisation understanding of molecular techniqeus such as ELISA, MSD as well as being experienced working in a regulated environment.

Responsibilities

• Lead end-to-end delivery of regulated studies (GLP/GCP).
• Make robust scientific decisions aligned with EMA and FDA guidance.
• Oversee method validation and sample analysis with scientific authority.
• Act as primary client contact, building strong partnerships and supporting programme progression.
• Ensure timely delivery of high-quality data and study reports.

Qualifications

• Degree in Biological Sciences, Biochemistry, Immunology, or related field.
• Experience in a GxP laboratory (GLP/GCP preferred).
• Knowledge of immunoassay platforms (e.g. ELISA, LBA, MSD) is advantageous.
• Strong understanding of EMA/FDA bioanalytical validation guidelines.
• Excellent communication skills with ability to present scientific data clearly.

Pay range and compensation package

Salary - (-35,000 to -42,000 DOE)