Study manager I

• Has overall responsibility for the technical conduct of assigned studies. Monitors and maintains compliance with appropriate SOPs, GLPs, regulatory guidelines, and study-specific protocols.
• Monitors progress and status of assigned studies. Ensure that all experimental data, including observations of unanticipated responses, are accurately recorded and verified.
• Develops protocols and ensures that the protocol, including any changes, is approved and is in compliance with the appropriate SOPs, GLPs, and regulatory agency guidelines.
• To be responsible for on time delivery targets (protocols, results, reports).
• Work with SMEs to troubleshoot assays

• Have in-depth and up to date knowledge of national and international GLP/GCP regulations and their application to the work area, SD roles and responsibilities, and organization of multi-site studies.
• Addresses quality assurance audits relating to studies and participate in client discussions on report issues. Ensures all document/data clarifications are completed within specified timelines.

• Develop teamwork with study team, business development, QA and other departments within the business
• Support and encourage the development of team members
• Liaise with other collaborating departments to facilitate effective conduct of projects.
• May conduct scientific peer review for protocols and reports and provide training for other study managers

• To evaluate existing departmental procedures and systems and participate in process improvements

• Have in-depth knowledge of relevant assays; and be able to advise internal/external clients on standard method validation and standalone study designs
• Maintains familiarity with routine study procedures/analysis methods and becomes familiar with specialized study procedures/analysis methods.
• To remain current with assay capabilities within I&I.

• Actively participates in client visits and activities
• Assists in assessing client interest and technical feasibility of new immunotoxicology assays.
• Proactively manage client and study changes to meet timelines and ensure all additional costs are captured (work scopes) communicates changes with study team and management

• Participates in the planning and designing of new techniques and leads method validation and standalone studies. Ensures that method development/validation and standalone activities are properly documented and conducted in accordance with SOPs and Good Scientific Practice.
• Stays current on new and emerging technologies and discoveries and provides input on new assays being developed.

• Make effective use of CMS for scheduling and all resources (people, equipment and materials)
• Ensure that all studies are archived according to current SOP
• Actively collaborate globally across I&I for successful planning and execution of the role.
• To ensure that their line manager and study director are kept fully updated on the technical and financial progress of their developments and validations.
• To undertake other duties and responsibilities as may be allocated from time to time by the line manager.

• Knowledge and practice of Health and Safety, including, personal protective equipment and COSHH (COSHH: UK based employees only).

• *Internal: Other I&I personnel globally. ED scientific, operational and administrative personnel. All personnel associated with the smooth running of studies.
• *External: All clients and representatives. External QA personnel. Regulatory inspectorate personnel. Vendors of equipment and consumable supplies.

• Preferably master degree in cell biology or immunology more than 5 years working experience in CRO company or PhD degree in cell biology or immunology with related research or working experience
• Deep knowledge in flow cytometry analysis, cell-based assay, multiplex cytokine analysis, ELISA and dd-PCR/digital PCR etc.
• Strong English writing and communication skills.
• Skilled in conducting experiments, compiling data and organizing document according to FDA, EMA and NMPA regulatory requirements.
• Experience of client management and technical expertise in the relevant business line will have been gained prior to this role.
• The job holder will have developed skills and competencies in the basic study types.
• Wins Client Loyalty
• Leads by example
• Good organizational and time management skills required.
• Good communication skills required.
• Good user knowledge of software applications required.
• To have good verbal, numerical and visual skills and excellent manual dexterity.
• To help foster a high professional standard and encourage good staff relationships.
• To be conscientious, disciplined, flexible and adaptable, having a sense of responsibility and to ensure that work is performed accurately and precisely and in a timely manner.

Labcorp