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.