Key Responsibilities and Required Skills for a GLP Study Manager

🎯 Role Definition

The GLP Study Manager is the cornerstone of non-clinical development programs, serving as the central point of contact and operational lead for outsourced toxicology, safety pharmacology, and DMPK studies. This individual holds the ultimate responsibility for the successful design, execution, and reporting of regulated non-clinical studies, ensuring they meet the highest standards of scientific integrity and regulatory compliance. Acting as the primary liaison between internal cross-functional teams and external Contract Research Organizations (CROs), the Study Manager's diligence and oversight directly support critical regulatory submissions and the advancement of novel therapeutics to patients in need.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Research Associate (Toxicology, Bioanalytical)
Study Coordinator or Study Technician at a CRO
Associate Scientist (Pharmacology, In-Vivo Biology)

Advancement To:

Senior or Principal GLP Study Manager
Associate Director, Non-clinical Development / Toxicology
Director, Preclinical Safety Assessment

Lateral Moves:

R&D Project Manager
Regulatory Affairs Specialist/Manager
Clinical Trial Manager

Core Responsibilities

Primary Functions

Serve as the single point of control for assigned non-clinical studies, meticulously overseeing all phases from study design and protocol finalization through in-life monitoring, data analysis, and final report delivery.
Lead the selection, qualification, and auditing process for Contract Research Organizations (CROs), conducting site visits, evaluating capabilities, and negotiating contracts and study budgets to ensure optimal partnerships.
Author, review, and approve comprehensive study protocols, amendments, and study plans, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) regulations and international guidelines (e.g., FDA, EMA, ICH, OECD).
Act as the Sponsor's representative and primary monitor for all outsourced studies, ensuring transparent communication and timely resolution of any issues, deviations, or unexpected findings that arise during study conduct at the CRO.
Critically review and interpret complex toxicology, safety pharmacology, and ADME study data in real-time and in draft reports, collaborating with internal subject matter experts to assess findings and their impact on the drug development program.
Manage the entire lifecycle of study-related documentation, including the timely review of draft reports, coordination of internal expert reviews, and finalization of high-quality study reports suitable for global regulatory submissions.
Proactively manage study timelines and budgets, tracking milestones and expenditures, and communicating any potential variances to senior leadership and project teams.
Coordinate the shipment and reconciliation of test articles and other critical study materials, ensuring proper documentation and chain of custody are maintained throughout the process.
Organize and lead key study events, including pre-study meetings, internal data review meetings, and study close-out activities, ensuring all stakeholders are aligned.
Review and approve CRO-generated invoices against study progress and contractual agreements to ensure financial accuracy.
Ensure all study records, data, and specimens are properly archived at the conclusion of the study in compliance with regulatory requirements and company policy.
Provide expert non-clinical operational support for regulatory submissions, including contributing to the authoring and review of IND, CTA, NDA, and BLA sections.
Function as the Study Director or a key scientific contributor on internal studies when required, applying the same rigor as for outsourced activities.
Facilitate the transfer of bioanalytical methods to CROs and oversee method validation and sample analysis to ensure data quality and integrity.
Monitor study conduct on-site at the CRO as needed to observe critical phases, build relationships, and ensure protocol and GLP compliance.
Drive the preparation of non-clinical data for internal governance meetings and external presentations, clearly articulating study results and their implications.
Maintain a comprehensive understanding of the assigned compound's development plan, providing strategic input on the non-clinical safety assessment strategy.

Secondary Functions

Support ad-hoc data requests from project teams and contribute to exploratory data analysis to inform future study designs.
Contribute to the continuous improvement of internal processes, standard operating procedures (SOPs), and best practices for non-clinical study management.
Collaborate with business units and project management to translate non-clinical data needs into clear operational and engineering requirements for data systems.
Mentor junior staff and colleagues on the principles of GLP and effective study management, fostering a culture of quality and compliance.

Required Skills & Competencies

Hard Skills (Technical)

Deep, hands-on knowledge of Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and other relevant global regulatory guidelines (ICH, OECD, MHLW).
Proven proficiency in the design, conduct, and interpretation of a wide range of in-vivo toxicology and safety studies (e.g., general toxicology, DART, genetic toxicology, carcinogenicity).
Experience with managing non-clinical studies for various therapeutic modalities, such as small molecules, biologics, oligonucleotides, or cell/gene therapies.
Strong scientific background in toxicology, pharmacology, biology, or a related discipline, enabling critical review of study protocols and data.
Experience with toxicology data management software (e.g., Pristima, Provantis) and an understanding of the SEND (Standard for Exchange of Nonclinical Data) format.
Competency in budget forecasting, financial tracking, and contract negotiation for outsourced research services.
Experience in authoring or contributing significantly to regulatory documents (e.g., INDs, IBs, CTAs).

Soft Skills

Exceptional project management skills, with a proven ability to manage multiple complex studies simultaneously without sacrificing quality or attention to detail.
Superior written and verbal communication skills, capable of effectively conveying complex scientific information to diverse internal and external audiences.
Strong negotiation and influencing skills, particularly when managing relationships, timelines, and deliverables with external CRO partners.
Excellent problem-solving and critical-thinking abilities, with a solutions-oriented mindset for addressing unexpected study challenges.
Meticulous organizational skills and an unwavering commitment to quality and compliance.
High level of interpersonal skill, with the ability to build strong working relationships and collaborate effectively within a cross-functional matrix environment.

Education & Experience

Educational Background

Minimum Education:

Bachelor's Degree (BS/BA) in a scientific discipline.

Preferred Education:

Master's (MS), PhD, or Doctor of Veterinary Medicine (DVM).

Relevant Fields of Study:

Toxicology
Pharmacology
Biology or Molecular Biology
Veterinary Medicine or Animal Science

Experience Requirements

Typical Experience Range:

A minimum of 5-8 years of relevant experience in the pharmaceutical, biotechnology, or CRO industry, with a focus on non-clinical/preclinical development. A significant portion of this experience must involve direct management or monitoring of GLP-regulated studies.

Preferred:

Direct experience acting as a Study Monitor or Study Director, preferably on the sponsor side, is highly desirable. Experience managing a portfolio of studies across different phases of drug development is a significant plus.