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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