Study Director - Physical Chemical Testing

Study Director - Physical Chemical Testing
LabCorp
Eye, United Kingdom
Job Responsibilities:
Act as GLP (Good Laboratory Practice) Study Director for studies to which they are appointed by management in accordance with the requirements of UK Statutory Instrument 1999 No. 3106 The Good Laboratory Practice Regulations 1999, including subsequent amendments and in line with OECD GLP expectations
To perform the duties of a Study Director/Principal Investigator for studies allocated by Management and ensure that a Study Plan conforming with the intentions of the study design agreed with the Sponsor is prepared, signed and circulated
Ensure all standard test methods meet the current requirements of specific regulatory or test guidelines and ensure that the agreed timelines are consistent with the Sponsors needs and/or agreed company start up times
Ensure that test and control items have been suitably tested for identity, stability etc. and that all necessary technical data regarding known toxicity, hazards of the test item or related materials have been obtained from literature searches and ensure that technical staff are aware of known hazards relating to a particular test item
Monitor the status of observations made during the study and ensure the responses are fully documented. Maintain an overview of the implication of these observations
Review all data to ensure its accuracy and that checking procedures have been observed. To ensure that the study is compliant with GLP and that suitable responses/actions are made following Quality Assurance Audit
Be aware of the study status, anticipate problems that may affect the schedule date, purpose or integrity of the study. To make interim decisions regarding necessary amendments, to document such changes and to agree them with the Study Sponsor. To communicate with the Sponsor and Departmental and Project Management as required with particular regard to problem areas which may affect completion date or content of the study.
To inform the Sponsor of the results as soon as possible after the study completion date. To prepare draft and final reports ensuring the report is concisely and accurately written, reflects the raw data and includes all relevant information
To transfer all study data and reports to the Archive in a timely manner following the issue of the final report, in accordance with Company procedures and SOPs
To plan on a weekly basis schedules for allocated studies, ensuring that the earliest possible start date, consistent with the Sponsor's needs or agreed company start up and inform the appropriate manager of any proposed alteration in the planned schedule
Maintain the computerised monitoring system for studies such that the information is up to date to enable study monitoring by their supervisors and other departments such as Quality Assurance
Where appropriate co-ordinating the supply of test vessels and equipment in conjunction with other members of staff thereby ensuring their availability for study start up
To maintain close verbal liaison with other staff concerning study activities and general housekeeping
Respecting all departmental and company policies concerning signing-in, sick leave, holidays, overtime, safety, COSHH, GLP/GMP, SOPs, etc.
Minimum Qualifications:
Degree in Chemistry
Additional Job Standards:
Used instrumentation in industry with one or more of the following: LC-MS/MS, GC-MS, HPLC-uv
Overseen studies or performed a number of physical chemical testing studies along with study design to GLP and worked as a Study Director
Attention to detail and consistent accuracy whilst managing multiple changing priorities
To keep up-to-date with trends in relevant areas of Physical Chemical testing. Review specific topics as necessary so as to be able to discuss with Sponsors
To assist in the training, supervision and mentoring of technical staff and trainee Study Directors
Provide advice and support to internal and external customers relating to any study and non‑study related topics
Travel as necessary, or to be available in-house to meet current and prospective sponsors to discuss existing and future studies
To perform those duties of other members of staff absent due to sickness, holidays or training. Overtime may be required in response to work-load demands
This is an office based role and required excellent written and verbal communication, time management and organisational skills with the ability to manage multiple studies
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