ACM Global Laboratories - Sr. Study Manager Small Molecule

ACM Global Laboratories – Sr. Study Manager Small Molecule

Job Title: Sr. Study Manager Small Molecule

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, 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 with company SOPs, policies, protocols, study plans, analytical methods and regulatory standards.
• Work to a high standard of precision and accuracy and 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.
• 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 fully knowledgeable with the current concepts and principles of GLP, GCP and COSHH.
• Follow the company’s Standard Operating Procedures (SOPs) and maintain individual training file.
• Take lead regarding procedural updates and training required in response to changes/updates to regulatory and industry standards.
• Communicate effectively with team members and discuss ideas in an open and professional manner.
• Manage schedules and commitments effectively and efficiently.
• Promote best practices within working area(s).
• 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 monthly operational schedules are executed in line with ACM commitments and client expectations.
• Monitor study-specific budgets and operational costs.
• Ensure management is fully informed, in a timely manner, about day-to-day operations and any deviations from the goals.
• Own operational improvements and implement measures for better compliance, productivity, and profitability.
• Understand the ACM business and scope of work in relation to the cost of the study.
• Support new business development activities as required.
• Work closely with Commercial and Management teams to drive new business.
• Recognize issues and potential issues and make correct decisions on how to resolve/prevent.
• Lead team through the process of change and address obstacles and resistance.
• Drive process improvements.
• Develop and train junior team members. May act as Line Manager for 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.

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