Job Description
The Study Manager position at Precision Medicine Group, located in Frederick, MD, leads and directs scientific work to support assay analysis for regulated and commercial diagnostic studies across various scientific teams. This role involves strategically leading projects, communicating with external partners, and monitoring project financial budgets.
The role involves:
- 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 laboratory readiness.
- Ensuring effective study assay scheduling and records accuracy.
- Defining optimal operational strategy, timeline, resourcing, and budget needs.
- Facilitating hand-off and kick-off meetings to identify potential risks.
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.