Project Lead Study Director

Location: Cheshire

Contract: Full

Industry:

Salary:

Responsibilities

Management of assigned regulatory studies and key contact for clients for assigned

Handling client requirements and timescales, liaising with business development executives in the production of quotes as

Responsible for scientific integrity and regulatory compliance of assigned

Review client documentation such as study protocols, lab manuals, and data transfer

Request and schedule appropriate resources to ensure timely completion of assigned

Preparation of bioanalytical study and Review of

Ensure the data and laboratory processes are in accordance with GLP/GCP and good documentation

Responding to QA audits and providing regular study updates to Project Leader

Requirements

BSc degree in life sciences or chemistry-related

At least 3 years experience working in a regulatory bioanalytical

Experience working within a GLP/GCP accredited

Experience in Validating Methods to FDA/EMA guidelines an

Hands-on experience in using LC-MS/MS, Sciex and Waters LC-MS/MS systems an

Knowledge of scientific software platforms such as Analyst, Masslynx, UNIFI, WATSON, Softmax Pro, and ELN an

Experience in Bioanalytical Method Development an

Strong interpersonal skills

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