ACM Global Laboratories - Sr. Study Manager Small Molecule

ACM Global Laboratories – Sr. Study Manager Small MoleculeJob Title: Sr. Study Manager Small MoleculeCategory: OtherClosing Date: 22/10/2025Department: BioALocation: York, UKSchedule: Days; Monday – FridaySign On Bonus: Up to 25% Sign-On/Relocation Bonus AvailableSUMMARYACM 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.RESPONSIBILITIESAct 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 QUALIFICATIONSB.Sc in Chemistry or related subject.Minimum of 6 years study management experience in regulated bioanalysis. #J-18808-Ljbffr