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Laboratory Study Supervisor

Employer
Simbec-Orion
Location
Merthyr Tydfil, United Kingdom
Salary
Competitive
Start date
24 Jan 2022
Closing date
12 Feb 2022

View more

Discipline
R & D , Laboratory
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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.

Summary of the Position:


We are looking for a Laboratory Study Supervisor to join our Laboratory Services.

The Laboratory Study Supervisor will be a key role within the Laboratory Services department, ensuring the studies are setup in accordance with related working documentation, accountable for the authorisation and reporting of safety data throughout the conduct of a study and responsible for all close out activities, in line with current Standard Operating Procedures (SOPs). You will act as a point of contact for internal and external Data Management teams, ensuring the approval and release of laboratory results for the business and sponsors are in accordance with Data Transfer Plan's (DTP). You will ensure that quality and compliance standards meet the various regulatory requirements (GCP and GLP) and ISO 17025: (2017) whilst effectively communicating, liaising and where needed escalating with team members and other stakeholders.

Key Accountabilities:
  • Approval and release of Pathology safety data results throughout the clinical conduct of a study.
  • Responsible for the set up and ongoing implementation of clinical studies within the Clinaxys LIMS system and ensuring all stages of the process have been fully executed.
  • Ensure that all QC check procedures relating to the set up of a clinical study within Clinaxys have been fully executed in a clear, accurate and timely manner.
  • Ensure that any study related changes that require updates to Clinaxys LIMS system during study conduct have been fully executed.
  • Laboratory data management of clinical studies, including review and implementation of Data Transfer Plans, including data reconciliation and sharing of study data through required formats (ie. lab listings and end of study extracts).
  • Conduct QC checks on study-related documentation where required.
  • Ensure that work performed adheres to good practice regulations and guidelines.
  • Assist in the implementation of relevant standard operating procedures and working instructions.
  • Communicate the status of work being performed and escalate where appropriate to Laboratory Management and Laboratory Project Management.

Minimum Requirements:

Essential:
  • Biomedical Science degree or equivalent
  • High level of attention to detail
  • Previous experience and basic skill set of a LIMS system
  • Excellent computer skills including word processing and spreadsheet applications
  • Ability to work in line with standard operation procedures and working instructions
  • Strong interpersonal and communication skills, with the ability to develop effective working relationships with team members, managers and other departments
  • Ability to prioritise workload and handle multiple tasks at one given time by utilising effective organisational and time management skills
  • Previous experience in working in a regulated environment (ISO 17025 15189) or GCLP)
  • Knowledge of clinical testing and parameters

Desirable:

  • Previous experience using Clinaxys LIMS system
  • Previous experience of working within a Clinical Research Organisation or similar field
  • Experience or knowledge of conducting research work either in a hospital laboratory placement and/or relevant experience gained using similar scientific and analytical techniques
  • HCPC ((health care professional council) registered


Simbec Orion Job Profile - Laboratory Study Supervisor.docx




Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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