Study Manager

Job Description

The Study Manager role at Precision Medicine Group involves leading and directing scientific work to support the analysis of assays for various regulated studies. This includes non-regulated, GLP-regulated, GCP-regulated, and commercial diagnostic studies across scientific teams like Bioanalytical, Companion Diagnostic, Flow Cytometry, and Cell Biology. The Study Manager works across multiple teams to deliver study milestones within cost, time, and quality requirements. They strategically lead projects and communicate with external partners and consultants, while also monitoring project financial budgets.Responsibilities:

• Managing multiple projects and ongoing work activities.
• Acting as the main source of study information.
• Leading study-level status reporting.
• Managing study timelines, budgets, and quality targets.
• Serving as the initial point of communication for customer issues.
• Reviewing lab-delivered data for accuracy and quality.
• Ensuring method development, validation, and bioanalytical reports are completed on time.
• Ensuring all required documentation and materials are in place for each stage of development and validation.
• Ensuring effective study assay scheduling and records accuracy.
• Defining optimal operational strategy, timeline, resourcing, and budget needs.
• Establishing and ensuring adherence to operational standards and best practices.
• Facilitating hand-off and kick-off meetings to identify potential risks.
• Ensuring project risks are discussed with customers and senior leaders.
• Identifying and proposing strategies for preventing or correcting significant problems.

Requirements:

• Bachelor’s degree in a life science or related field & 6 years of related experience OR Master’s Degree or higher & 2 years of related experience.
• Minimum of 4 years of working for a laboratory in the life sciences or biotech arena.
• 2 years experience of clinical trials study or project oversight.
• Outstanding leadership skills.
• Excellent judgment and decision-making skills.
• Knowledge of project management principles and application.
• Financial acumen with knowledge of budgeting, forecasting, and resource management.
• Knowledge of regulatory guidelines and directives.
• Knowledge of laboratory and laboratory terminology.
• Able to read, write, and fluently speak and comprehend the English language.
• Proven track record of being a team player.

The role offers:

• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation.