Study manager I

Job Summary:

The Study Manager ensures that the studies are carried out to the required standards and approves the study data. The Study Manager will be responsible for the management of analytical studies/phases of studies in the capacity of a Study Director, Principal Investigator, or Responsible Scientist. The Study Manager is the single point of study control and has overall responsibility for the scientific, technical and regulatory conduct of studies allocated to him/her as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance.

Essential Job Duties:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

General Job Responsibilities

• 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.