Position Summary:

The Principal Study Manager will act as the person responsible to lead and direct scientific work to support analysis of assays for non-regulated, GLP-regulated, GCLP-regulated and commercial diagnostic (CAP / CLIA) regulated studies across all scientific teams supporting Molecular and Tissue based biomarker testing. The Principal Study Manager will work effectively across multiple departmental teams to direct the delivery of study milestones within cost, time, and quality requirements. Strategically leads projects, as well as communicates with external partners, consultants, and monitors project financial budgets to ensure we delivery study milestones on time and within the defined scope of work.

Essential functions of the job include but are not limited to:

• Independently manages multiple projects and the ongoing work activities associated with a project across the PfM Specialty Lab.
• Act as a single, authoritative source of study information and leads study level status reporting per client; drives associated deliverables across all functions for assigned projects; accountable for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs.
• Reviews all lab delivered data to ensure accuracy and quality, and ensures all deliverables are completed on time.
• Responsible for ensuring all method development reports, validation plans and bioanalytical reports are completed on time and are accurate.
• Mentors less experienced Study Managers and assist in critical decisions.
• Ensure all required documentation and materials are in place so that the laboratory is ready for each stage of development and validation or sample analysis.
• Accountable to ensure effective study assay scheduling, proper records retention, and timely communications.
• Define optimal timeline, resourcing, and budget needs for execution of the study plans that define scope of work.
• Establish and ensure adherence to operational standards and best practices across projects.
• Ensures the timely execution of projects with a focus on quality deliverables. Facilitates hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans.
• Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with customers and senior leaders through appropriate escalation pathways.
• In conjunction with Project management, serves as the initial point of communication for customer issues. Communicate with customers regularly to obtain direction and feedback on implementing scope of work as well as performance to date.
• Identifies unusual or significant problems encountered during a study and proposes strategies for preventing or correcting significant problems with supervisor oversight.
• Assist other Study Managers with the identification and resolution of study or assay issues.

Qualifications:

Minimum Required:

• Bachelor’s degree in life science or related field & (e.g., engineering) & 10 years of related experience

OR

• Master’s Degree or higher level in a life science or related field, and 6 years of related experience

AND

• A minimum of 10 years of working for a laboratory in the life sciences or biotech arena.
• 5 years’ experience with clinical trial studies or scientific project oversight
  • in some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Other Required:

• Outstanding leadership skills
• Excellent judgment and decision-making skills
• Direct experience in oversight of molecular and/or tissue-based biomarker assays
• Experience working in a regulated environment, preferably GLP or GCP
• 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 laboratories and laboratory terminology
• Able to read, write, and fluently speak and comprehend the English language
• Proven track record of being a team player, willing to interact proactively and productively