Study Director - Physical Chemical Testing in Eye

Labcorp is seeking a Senior Study Director to join our team at Eye, Suffolk.

Work Schedule: Monday - Friday – 37.5hrs

Labcorp is a leading global life sciences company that includes contract research and developmental services to the pharmaceutical, medical technology, crop protection and chemical industries.

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.
• 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. 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. Make interim decisions regarding necessary amendments, document such changes and agree them with the Study Sponsor.
• 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.
• Inform the Sponsor of the results as soon as possible after the study completion date. Prepare draft and final reports ensuring the report is concisely and accurately written, reflects the raw data and includes all relevant information.
• 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.
• 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-ordinate the supply of test vessels and equipment in conjunction with other members of staff thereby ensuring their availability for study start up.
• Maintain close verbal liaison with other staff concerning study activities and general housekeeping.
• Respect all departmental and company policies concerning signing-in, sick leave, holidays, overtime, safety, COSHH, GLP/GMP, SOPs, etc.

Minimum Qualifications

• Degree in Chemistry.
• 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.
• 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.
• 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.
• 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 requires excellent written and verbal communication, time management and organisational skills with the ability to manage multiple studies.
• Due to the remote location of this site, there are no public transport links available.

Role Overview

The role of a Senior Study Director is to ensure that studies are conducted to agreed schedules by liaising with key staff involved in study conduct and maintaining an awareness of all aspects of the studies ensuring that a Study Plan is prepared, approved and implemented. Informing the Sponsor of study progress and preparing study reports that accurately reflect the raw data obtained. To ensure suitable levels of compliance of all laboratory data, documentation and procedures conducted within the department and satisfy the requirements of GLP and Company SOPs and provide advice and support to internal and external customers relating to study designs and regulatory issues, as required.

Benefits

• Competitive salaries.
• No weekend work.
• Wider benefits package including pension and generous holiday allowance.
• Excellent relocation package (subject to criteria).

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.