ACM Global Laboratories - Sr. Study Manager Small Molecule

Job Title:

Sr. Study Manager Small Molecule

Category:

Other

Closing Date:

22/10/2025

Submit Application to https://rrhs.wd5.myworkdayjobs.com/en-US/acm/details/Sr-Study-Manager-Small-Molecule_REQ_204504

Job Title: Sr. Study Manager Small Molecule

Department: BioA  

Location: York, UK  

Hours Per Week: 37.5

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, so that ACM Bioanalytical Services can 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 to company SOPs, policies, protocols, study plans, analytical methods and regulatory standards. Ability to
• work to a high standard of precision and accuracy and to comply with all the laboratory's GLP/ GCP procedures.
• Responsible for generation of 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. Construct results tables and perform quality Control review.
• 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.
• Responsible to 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.
• The jobholder is expected to be fully knowledgeable with the current concepts and principles of GLP, GCP and COSHH and how to conduct their work and supervise others so that all work is compliant with the regulatory requirements for GLP, GCP and safe working practices.
• The jobholder must follow the company’s Standard Operating Procedures (SOPs) and maintain their individual training file.
• Expected to take the lead in regards to procedural updates and training required in response to changes/ updates to regulatory and industry standards affecting the department
• Communicates effectively with team members, and ability to listen and discuss ideas in an open and professional manner.
• Ensure that schedules and commitments are effectively and efficiently managed taking into account people, periods of leave, facilities and equipment
• Promotes best practices within working area(s).
• Drive the ACM Mission, Vision and Core Values with every interaction.
• Foster a culture that promotes quality, safety and ethical practices, customer focus and service and encourages individual integrity.
• Support the effective performance of the team and individuals to ensure the monthly operational schedules are executed in line with ACM commitments and client expectations
• Effectively monitors study specific budgets and operational costs, triggering and contributing to the generation of proposal amendments as required.
• Ensure management are fully informed, in a timely and transparent manner, the conduct of the day-to-day operations towards the achievement of its established goals and any deviations from the goals or company objectives.
• Owns operational improvements and implements measures that facilitate improved compliance, productivity and profitability.
• Understand the ACM business and scope of work in relation to the cost of the study and appreciate impact of change on work scope.
• Supports new business development activities as required, including providing information for new sales enquires (RFIs, RFPs).
• Works closely with Commercial and Management teams to drive new business; seeks out ways to increase scale and scope of the Bioanalytical Services business offering
• Can recognize issues and potential issues and can make correct decisions on how to resolve/prevent.
• Knows limitations of own knowledge and escalates where required.
• Leads team and others through the process of change and address obstacles and resistance, maintaining levels of engagement.
• Takes lead role in driving process improvements
• Takes lead role in developing and training junior team members. May act as Line Manager for junior team members
• Takes lead role in collaborating and integrating with wider ACM organization (PMs etc.)

REQUIRED QUALIFICATIONS

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