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.
The job role for the Study Manager (SM II) will include the direction of non-standard study types and an increased volume of work.
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.
Regulatory
- 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, 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.
Training/mentoring/leadership
- Fosters teamwork with study team, business development, QA and other departments within the business
- Providing advice and training to study management team during conduct of studies
- Liaise with other collaborating departments to facilitate effective conduct of projects.
- Will support conduct of scientific peer review for protocols and reports and provide training for other study managers.
- Presents and publishes scientific posters and/or presentations at external meetings.
Process Improvement
- To evaluate existing departmental procedures and systems and instigates in process improvements.
Understanding of I&I assays
- Have in-depth knowledge of relevant assays; and be able to advise internal/external clients on standard 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.
Client facing roles
- May host 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.
New assays/feasibility work
- 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.
Misc. items
- 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.
Health and safety
- Knowledge and practice of Health and Safety, including, personal protective equipment and COSHH.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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