Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives. THE ROLE
We are looking for a Laboratory Study Manager to join our Laboratory Services Department where you will have accountability for people and resource management, processes, and compliance associated with the setup, and approval of safety results at Simbec Orion. You will be responsible for the transfer of all safety data to internal and external Data Management Teams and will ensure quality and compliance standards meet the various regulatory requirements (GCP and GLP) and ISO 17025: (2017) standards whilst effectively communicating and liaising with team members and other stakeholders. KEY ACCOUNTABILITIES
- Oversee the day-to-day operations of the Laboratory Study Management team, ensuring study expectations are met for all projects.
- Assist with operational tasks in Laboratory Study Management when required.
- Act as Head of Laboratory Study Management delegate in their absence.
- Assist in the implementation of processes and quality improvements.
- Maintain and record departmental trackers/logs to demonstrate data metrics.
- Ensure all processes in Laboratory Study Management are documented and executed in line with the expected regulations and data integrity guidance.
- Communicate the status of work performed and escalate where appropriate to the Head of Laboratory Study Management and the Laboratory Project Manager.
- Review and approve data generated from the onboarding of new testing requirements.
- Prepare quality documentation (standard operational procedures, non-compliances, file notes etc.) within expected timeframes.
- Act as Point of Contact for internal and external Data Management Teams.
- Approve and release Laboratory Safety results in line with expected standards and act as a LIMS (Lab Information Management Software) superuser.
- Document procedures that are undertaken in a clear, accurate manner in accordance with the principles of ALCOA+ and apply Quality Control (QC) to ensure their accuracy.
- Accountable for monitoring, reviewing and approving uncertainty of measurement data.
- Mentor employees, and where appropriate, identify training and development needs
- Maintain personal training records to demonstrate competency.
- Biomedical Science degree or equivalent degree
- Previous experience onboarding new testing requirements
- HCPC registered Biomedical Scientist in blood science or multi-disciplinary (including haematology and biochemistry)
- Previous experience in approving clinical test data
- Expertise managing multiple projects and managing competing priorities, to ensure delivery of results on time and on budget
- Excellent verbal and written skills, with ability to tailor communication to a variety of internal and external stakeholders
- Previous experience in working in a regulated environment (IS0 17025, 15189 or MHRA GCP)
WHY YOU SHOULD JOIN US
- MSc, PhD or MBA in a relevant discipline
- Previous line management experience
- Experience of conducting research work either in a hospital laboratory placement and/or relevant experience gained using similar scientific and analytical techniques
- Good understanding of MHRA Phase I Accreditation scheme requirements.
- Working knowledge of laboratory testing in a GMP environment.
- Uncertainty of measurement experience.
Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.
We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.
With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.