ACM Global Laboratories - Team Lead Study Manager Small Molecule

The primary role of a Study Manager Team Lead of Small Molecule is to lead the direct line management of Study Managers.

RESPONSIBILITIES

• Act as Study Manager/Principal Investigator for regulatory and non-regulatory studies.
• Direct line management of Study Managers, including recruitment and training.
• Ensure the effective performance management of teams and individuals, providing that all members have clearly defined roles, responsibilities and objectives, and any instances of below standard performance/behavior are managed according to appropriate procedures.
• Ensure studies are conducted in compliance with 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.
• Review and approval of Quality Assurance study specific and non study specific audit reports.
• 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, lead and supervise others so that all work conducted in the department 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.
• Provide Leadership to enable 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 and the York Site Leadership Team 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. Support the development of the annual operating plan in line with the business unit strategy.
• 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 inquiries (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.
• Effectively monitors budgets and operational costs; uses financial information to assist in decision making regarding staffing levels, workload and process management.
• Excellent time management skills, and can coordinate and manage multiple priorities for self and others as required.
• 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.
• Provide effective leadership for the department, by effectively communicating business goals, agreeing team and individual objectives and offering timely feedback.
• Takes lead role in collaborating and integrating with wider ACM organization (PMs etc).

REQUIRED QUALIFICATIONS

• B.Sc in Chemistry or related subject
• 8 years study management experience in regulated bioanalysis