Project Leader (Study Director)

Location: Cheshire East.

Contract: Full Time.

Industry: CRO.

Salary: Competitive.


  • Management of assigned regulatory studies and key contact for clients for assigned studies.
  • Handling client requirements and timescales, liaising with business development executives in the production of quotes as required.
  • Responsible for scientific integrity and regulatory compliance of assigned studies.
  • Review client documentation such as study protocols, lab manuals, and data transfer agreements. 
  • Request and schedule appropriate resources to ensure timely completion of assigned studies.
  • Preparation of bioanalytical study and Review of SOPs.
  • Ensure the data and laboratory processes are in accordance with GLP/GCP and good documentation practice.
  • Responding to QA audits and providing regular study updates to Project Leader Management.


  • BSc degree in life sciences or chemistry-related subject.
  • At least 3 years’ experience working in a regulatory bioanalytical laboratory.
  • Experience working within a GLP/GCP accredited facility.
  • Experience in Validating Methods to FDA/EMA guidelines an advantage.
  • Hands-on experience in using LC-MS/MS, Sciex and Waters LC-MS/MS systems an advantage.
  • Knowledge of scientific software platforms such as Analyst, Masslynx, UNIFI, WATSON, Softmax Pro, and ELN an advantage.
  • Experience in Bioanalytical Method Development an advantage.
  • Strong interpersonal skills

I am looking forward to having a chat with you if you are suitable for this role. For more information on this exciting opportunity please email a copy of your CV in MS WORD format to using Project Leader (Study Director) as the Subject.

To stay up to date with the latest and exciting opportunities, please follow us on LinkedIn via

Job Category: Healthcare
Job Location: Cheshire East

Apply for this position

Allowed Type(s): .pdf, .doc, .docx