Project Lead (Study Director) Cheshire
Job description
Location: Cheshire
Contract: Full Time.
Industry: CRO.
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
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Job Type: Full-time
