Study Manager Small Molecule

ACM Global Laboratories

SUMMARY

The focus of this role is oversight and management of development, validation and sample analysis studies within the Bioanalytical Services Small Molecules group. You will be responsible for delivering high quality results to our Sponsors and Clients in compliance with GLP and GCP.

The Study Manager – Small Molecules possesses a deep understanding of the analytical techniques and regulatory requirements relating to bioanalysis, method development, validation, and sample analysis and is responsible for carrying out study management duties to ensure efficient and effective testing is completed and reported in the required turnaround time.

OFFERINGS

• Auto Enrolment Pension
• Comprehensive Benefits Package
• Working within a Global organisation
• Career Advancement Opportunities including Apprenticeships
• Offering Sponsorship Opportunities

At ACM Global Laboratories our employees are empowered to progress in a career that creates purposeful and meaningful work. ACM impacts the medical field with over 500 Clinical Trials and 2 million CT tests annually. The Study Manager-Small Molecule roles works within a dedicated, collaborative team in a newly refurbished office and laboratory environment. The role offer the opportunity for growth with the department which is seeing an unprecedented growth in business.

STATUS: Full-time (but other working patterns will be considered)

POSITION TYPE: Permanent, Contract, Temp

LOCATION: On-site

DEPARTMENT: Bioanalytical Services/Study Management

SCHEDULE: Monday – Friday

ATTRIBUTES:

• A minimum of 3 years of study management experience in clinical and/or preclinical studies
• Strong background knowledge of small molecule analysis in support of PK and PD studies.
• Experience working in a regulatory environment, managing studies that are compliant with GLP/GCP
• Experience in a client facing role with the ability to provide high level advice and guidance to clients
• Non-Smoker: due to the nature of some of the testing carried out in the laboratory

KEY RESPONSIBILITIES

• Quality. Follow and maintain the company s Standard Operating Procedure(s) ensuring that all work conducted by them conforms to applicable regulatory standards, and biological and chemical safety regulations (COSHH). Contemporaneously maintain their individual training file, and ensure their work is carried in compliance to both standard operating procedure(s) and level of training recorded. Understand and use ACM computer systems/policies and their associated software in order to carry out requisite duties of the post. Support departmental management in the effective running of the department, including owning/driving quality issue resolution and process improvement activities.
• Study Management. Undertake study management of assigned studies. This includes, but is not limited to: managing Sponsor/Client/internal ACM teams liaison activities. Generation of Study Protocols, Data Transfer Agreements and Analytical Reports. Batch construction for validations and sample analysis, in accordance with company SOPs and regulatory requirements. Manage quality investigations and/or issue resolution; Corrective Action/Preventative Action (CAPA) system management. Ensure all data is archived in accordance with company SOPs and regulatory requirements. Responsible for financial monitoring for all assigned studies, ensuring all work is adequately accounted for during the revenue recognition process.
• Technical. Train others, in the scientific theoretical methodology involved in the bioanalysis of small molecules including sample management, batch preparation and data analysis. Understand and be capable of carrying out PK/TK and method validation/sample analysis studies. Maintain an efficient data record with an appropriate audit trail. To understand how to use analytical instrumentation and associated software to process and report analytical results and to understand the importance of audit trails, security and validation.