Principle Study Manager

Precision for Medicine•Houston, TX

4d•$147,300 - $220,900

About The Position

The Principal Study Manager leads and directs scientific work supporting assay analysis for non-regulated, GLP-regulated, GCLP-regulated, and commercial diagnostic (CAP/CLIA)-regulated studies across scientific teams working on molecular and tissue-based biomarker testing. The role coordinates across departments to deliver study milestones within cost, time, and quality requirements, leads projects strategically, communicates with external partners and consultants, and monitors financial budgets. The Principal Study Manager independently manages multiple projects and their ongoing activities across the PfM Specialty Lab. This person serves as the authoritative source of study information, leads client-specific status reporting, drives cross-functional deliverables, and is accountable for study timelines, budgets, and quality targets. The role reviews laboratory data and ensures the accuracy and timely completion of deliverables, including method development reports, validation plans, and bioanalytical reports. It also mentors less experienced Study Managers and assists with critical decisions. The position ensures required documentation and materials are in place for development, validation, and sample analysis; manages assay scheduling, records retention, and communications; and defines timelines, resourcing, and budgets for study plans. The Principal Study Manager establishes operational standards and best practices, facilitates hand-off and kick-off meetings, identifies risks and contingency plans, and escalates issues affecting time, quality, or cost. In conjunction with Project Management, the role is an initial contact for customer issues and communicates regularly with customers to obtain direction and feedback. It identifies significant study problems and proposes corrective or preventive strategies with supervisor oversight, while also helping other Study Managers resolve study or assay issues.

Requirements

Bachelor’s degree in life science or a related field, such as engineering, and 10 years of related experience; or a master’s degree or higher in a life science or related field and 6 years of related experience.
At least 10 years of experience working for a laboratory in the life sciences or biotech arena.
At least 5 years of experience with clinical trial studies or scientific project oversight.
Outstanding leadership skills.
Excellent judgment and decision-making skills.
Direct experience overseeing molecular and/or tissue-based biomarker assays.
Experience working in a regulated environment, preferably GLP or GCP.
Knowledge of project management principles and their application.
Financial acumen, including knowledge of budgeting, forecasting, and resource management.
Knowledge of regulatory guidelines and directives.
Knowledge of laboratories and laboratory terminology.
Ability to read, write, speak, and comprehend English fluently.
A proven record of teamwork and willingness to interact proactively and productively.
Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Responsibilities

Independently manage multiple projects and ongoing work activities across the PfM Specialty Lab.
Serve as the authoritative source of study information and lead study-level status reporting for clients.
Drive study deliverables across functions and manage overall timelines, budgets, and quality targets.
Review laboratory-delivered data for accuracy and quality and ensure all deliverables are completed on time.
Ensure method development reports, validation plans, and bioanalytical reports are accurate and completed on time.
Mentor less experienced Study Managers and assist with critical decisions.
Ensure documentation and materials are ready for each stage of development, validation, or sample analysis.
Manage study assay scheduling, records retention, and timely communications.
Define timelines, resourcing, and budget needs for study plans and their scope of work.
Establish and ensure adherence to operational standards and best practices across projects.
Facilitate hand-off and kick-off meetings, identify potential risks, and develop and communicate contingency plans with the project team.
Communicate and escalate risks and contingencies affecting delivery time, quality, or cost to customers and senior leaders through appropriate pathways.
Serve, in conjunction with Project Management, as an initial point of communication for customer issues.
Communicate regularly with customers to obtain direction and feedback on scope implementation and performance.
Identify unusual or significant study problems and propose strategies to prevent or correct them, with supervisor oversight.
Assist other Study Managers in identifying and resolving study or assay issues.