ACM Global Laboratories - Sr. Study Manager Small Molecule

Glasgows; York; On-site; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Sr. Study Manager for Small Molecule studies in York. This role involves leading regulatory and non-regulatory studies while ensuring compliance with SOPs and regulatory standards. The successful candidate will oversee study management, provide technical direction, and drive operational improvements in a collaborative environment. With a focus on quality, safety, and ethical practices, you will support the team in aligning operational schedules with client expectations. If you are passionate about bioanalytical services and have a strong background in study management, this opportunity is perfect for you.

Benefits

Up to 25% Sign-On/Relocation Bonus

Professional Development Opportunities

Qualifications

• 6+ years of study management experience in regulated bioanalysis required.
• Strong understanding of GLP, GCP, and COSHH principles essential.

Responsibilities

• Lead as Study Manager for regulatory and non-regulatory studies.
• Ensure compliance with SOPs and regulatory standards.
• Manage schedules, budgets, and operational improvements.

Skills

Study Management

Regulatory Compliance

Technical Direction

Quality Assurance

Budget Management

Education

B.Sc in Chemistry or related subject

Tools

LC-MS/MS

Job description

ACM Global Laboratories - Sr. Study Manager Small Molecule

Job Title: Sr. Study Manager Small Molecule

Category: Other

Closing Date: 22/10/2025

Department: BioA

Location: York, UK

Schedule: Days; Monday – Friday

Sign On Bonus: Up to 25% Sign-On/Relocation Bonus Available

SUMMARY

ACM Bioanalytical Services (BioA) is a specialist analytical facility that provides a service measuring low concentration analytes (e.g. sub nanogram per milliliter) in biological matrices. The post-holder is expected to work efficiently and effectively to supply sponsors with an efficient and effective service.

RESPONSIBILITIES

• Act as Study Manager/Principal Investigator for regulatory and non-regulatory studies.
• Ensure studies are conducted in compliance with company SOPs, policies, protocols, study plans, analytical methods, and regulatory standards.
• Responsible for generating Study Plans, Data Transfer Agreements, Analytical Reports, and subsequent amendments.
• Document and complete any quality documentation (Quality issue, CAPA, deviation, change control) as appropriate and within the required timeframes.
• Responsible for addressing all study-related internal audit comments.
• Act as departmental lead with Sponsor/Client/internal teams for Bioanalytical activities conducted on assigned studies.
• Participate in internal and external quality assessment activities as required.
• Oversee LC-MS/MS method development and troubleshooting.
• Provide technical, practical, and scientific direction for work conducted.
• Ensure all data is archived in accordance with company SOPs and regulatory requirements.
• Review any protocol, study plan, report, SOP, or scientific paper as required.
• Be knowledgeable of current concepts and principles of GLP, GCP, and COSHH and how to conduct work and supervise others to ensure compliance.
• Follow the company’s Standard Operating Procedures (SOPs) and maintain an individual training file.
• Take the lead in procedural updates and training required in response to changes/updates to regulatory and industry standards affecting the department.
• Communicate effectively with team members and discuss ideas in an open and professional manner.
• Manage schedules and commitments effectively, considering personnel, periods of leave, facilities, and equipment.
• Promote best practices within working areas.
• Drive the ACM Mission, Vision, and Core Values with every interaction.
• Foster a culture that promotes quality, safety, ethical practices, customer focus, and service.
• Support the effective performance of the team and individuals to ensure operational schedules align with ACM commitments and client expectations.
• Monitor study-specific budgets and operational costs, contributing to proposal amendments as needed.
• Ensure management is informed in a timely and transparent manner about daily operations and any deviations from goals or objectives.
• Own operational improvements and implement measures for enhanced compliance, productivity, and profitability.
• Understand ACM's business and work scope in relation to study costs and the impact of changes.
• Support new business development activities, including providing information for new sales inquiries (RFIs, RFPs).
• Collaborate with Commercial and Management teams to drive new business and expand the Bioanalytical Services offering.
• Recognize issues and potential issues, making informed decisions on resolution/prevention.
• Understand personal knowledge limitations and escalate issues where necessary.
• Lead teams through change processes, addressing obstacles and maintaining engagement.
• Drive process improvements and develop/training junior team members.
• Collaborate and integrate with the wider ACM organization.

REQUIRED QUALIFICATIONS

• B.Sc in Chemistry or related subject.
• Minimum of 6 years study management experience in regulated bioanalysis.