Study Manager I

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

Study Manager I

Labcorp is seeking a Study manager I to join our I&I team in Shanghai, China.

Job Responsibilities:

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

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, 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.

Training/mentoring/leadership

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

Process Improvement

To evaluate existing departmental procedures and systems and participate 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 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.

Client facing roles

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

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 (COSHH: UK based employees only).

Principal Contacts and Scope of Communications

*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.

Minimum Qualifications:

PhD degree in cell biology or immunology with related research or working experience

Strong English writing and communication skills.

Deep knowledge in flow cytometry analysis, cell-based assay, multiplex cytokine analysis, ELISA and dd-PCR/digital PCR etc.

Preferred Qualifications:

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.

Strong experience in resolving complex and non-routine technical challenges, including assay instability, matrix effects, or instrumentation issues.

 

Additional Job Standards:

Experience in training, mentoring, or onboarding junior staff in laboratory techniques and troubleshooting.

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.

At Labcorp we have a passion for helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people and have a drive for service, then Labcorp could be a great next career step!

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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