Principle Study Manager

Precision for Medicine•Houston, TX

5d•$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 teams conducting molecular and tissue-based biomarker testing. The role works across departments to deliver study milestones within cost, time, and quality requirements, strategically leads projects, communicates with external partners and consultants, and monitors project budgets to ensure delivery within the defined scope of work. The position independently manages multiple projects and their ongoing activities across the PfM Specialty Lab. It serves as the authoritative source of study information, leads client-level status reporting, and drives study deliverables across functions. The role oversees study timelines, budgets, quality targets, laboratory data review, reports, documentation, assay scheduling, records retention, and communications. It also defines project resources and budgets, establishes operational standards, coordinates project handoffs and kickoffs, identifies and escalates risks, communicates with customers, and supports other Study Managers in resolving study or assay issues. The Principal Study Manager mentors less experienced Study Managers and contributes to critical decisions. The role requires a life science or related educational background, substantial laboratory experience, and experience with clinical trial studies or scientific project oversight. The position is eligible for a discretionary annual bonus and benefits including health insurance, retirement savings benefits, life insurance, disability benefits, parental leave, and paid time off for sick leave and vacation.

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 work experience in 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.
Proven ability to work as a team player and 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 project activities across the PfM Specialty Lab.
Serve as the authoritative source of study information and lead study-level status reporting for clients.
Drive project deliverables across functions and manage overall study timelines, budgets, and quality targets.
Review laboratory-delivered data for accuracy and quality and ensure 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 required documentation and materials are ready for each stage of development, validation, or sample analysis.
Oversee 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 handoff and kickoff meetings, identify potential risks, and develop and communicate contingency plans with project teams.
Ensure risks and contingencies affecting time, quality, or cost are discussed with customers and senior leaders through appropriate escalation pathways.
In conjunction with Project Management, serve 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.