Project Leader (Study Director)

Location: Cheshire East.

Contract: Full Time.

Industry: CRO.

Salary: Competitive.

Responsibilities

• 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.

Requirements

• 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 cv@specialistmedics.com using Project Leader (Study Director) as the Subject.

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