Study Director - Analytical Chemistry - Environmental Ecotoxicology

Labcorp; Huntingdon; Sur place; GBP 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

No weekend work

Pension and generous holiday allowance

Résumé du poste

Labcorp, Huntingdon site, is seeking an experienced Study Director to oversee analytical studies from planning through reporting. You will ensure that study plans meet sponsor expectations, are signed off, and documented in line with GLP and SOPs.

The role requires leadership across staff and to coordinate start-up and project timelines. We value expertise in analytical chemistry, data interpretation, report writing, and strong customer service communication.

Qualifications

• Significant experience as Study Director in Analytical Chemistry.
• Knowledge of GLP and regulatory guidelines.
• Ability to interpret data and write reports for studies.
• Experience in customer service communication.
• Proficient in project management.
• Ability to conduct literature reviews.

Responsabilités

• Lead studies to ensure plans, timelines, and sponsor expectations are met.
• Prepare and approve study plans, circulate and sign off.
• Ensure GLP compliance and QA procedures.
• Communicate study progress to Sponsor and management.
• Coordinate resources and study start-up.
• Prepare final reports and archive data.
• Train and mentor staff.
• Travel as needed.

Connaissances

Study Director

Analytical Chemistry

GLP knowledge

Regulatory guidelines

Project management

Literature review

Customer service

Formation

Degree in Chemistry

Description du poste

• Perform the duties of a Study Director/Principal Investigator for studies allocated by Management
• Ensure that Study Plans conform with the intentions of the study design agreed with the Sponsor is prepared, signed and circulated and all standard test methods meet the current requirements of specific regulatory or test guidelines
• Ensure that the agreed timelines are consistent with the Sponsors needs and/or agreed company start up times. Hold study start-up meetings, to ensure all key staff are conversant with all aspects of the study and to resolve any issues before treatment is started, to prevent unnecessary use of animals where applicable
• 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. To 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 compliant with Good Laboratory Practice 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, to document such changes and to 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
• Maintain computerised monitoring system for studies such that the information is up to date to enable study monitoring by their supervisors and other departments
• Communicate with Ecotoxicology in the conduct of studies
• Co-ordinate the supply of test vessels and equipment in conjunction with other members of staff thereby ensuring their availability for study start up
• Contribute to the general management of the Analytical department in areas outside of that required as a Study Director
• Travel as necessary, or to be available in-house to meet current and prospective sponsors to discuss existing and future studies
• Keep up-to-date with trends in relevant analytical areas. 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
• 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., We are looking for a 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. Ensuring 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.
  Degree in Chemistry

Additional Job Standards:

• Significant experience within a Study Director role in Analytical Chemistry
• Knowledge of GLP and regulatory guidelines
• Knowledge of data interpretation and report writing for studies
• Experience of customer service communication
• Proficiency in project management skills
• Ability to conduct literature review
• Due to the remote location of this site, there are no public transport links available
  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.
  Competitive salaries
• No weekend work
• Wider benefits package including pension and generous holiday allowance