Simbec-Orion
Laboratory Project Manager
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Our Mission
Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.
We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.
The Role
We are looking for a Laboratory Project Manager to join our Laboratory Services Department where you will provide specialist Project Management skills to effectively set-up and manage clinical research studies conducted within Laboratory Services, ensuring projects are delivered on time, within budget and to the agreed scope.
Will interact with key Laboratory Services employees and other stakeholders such as internal Project Managers on a regular basis to ensure all study tasks are executed. Will also be required to represent the business in communications with clients and other third-party vendors.
Key Accountabilities
- Facilitate and execute projects within scope and budget, whilst meeting deliverables and quality expectations, adhering to the principles of Good Clinical Practice (ICH-GCP) and in accordance with Standard Operating Procedures (SOPs), the UK Statutory Instrument No. 1031 (The Medicines for Human Use [Clinical Trials] Regulations 2004 and subsequent amendments) and other applicable guidelines.
- Act as the primary point of contact for the client and study team on assigned projects from the initiation through to the close-out of a project.
- Attend relevant study meetings such as Business Development handover and Kick-Off Meeting along with identifying and effectively managing study laboratory risks for the duration of a project.
- Deliver timely implementation and execution of all relevant set up activities. This may include but not limited to the Laboratory Service Plan (LSP), Sample Handling Manual (SHM), external Test Request Forms (TRF’s)/manifests and Data Transfer Plan (DTP), training material.
- Execute and/or QC checks of study set-up requirements within the Laboratory Information Management system (LIMs), including general set-up, visits, reference ranges and reflex testing in accordance with study requirements.
- Monitor the financial aspects of a project following initial Work Order review to final cost reconciliation activities. This will include but not limited to identifying and raising out of scope activities and performing monthly revenue activities.
- Perform laboratory data activities as required during the study, such as issuing accurate data for Dose Escalation Review meetings (DERM).
- Maintenance of the shared study drive, electronic Trial Master File (eTMF) including performing the reviews of the eTMF when initiated, and the laboratory study files from set-up to archive, including key correspondence, as applicable.
- Manage in scope study changes, ensuring appropriate documentation is executed and communicating with relevant team members to ensure the change is managed smoothly.
- Escalate study-related issues to Senior Laboratory Project Managers and/or Head of Laboratory Project Management.
- Act as a mentor for Associate Laboratory Project Managers and deputise for other members of the Laboratory Project Management team.
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Essential Skills Required
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- BSc in Life Science or Business degree or equivalent
- Project Management experience within a Laboratory or Clinical Research environment, with an understanding of Good Clinical Practice
- Excellent organisation and time management skills to manage multiple projects
- Ability to work to deadlines with changing priorities
- Excellent communication and negotiation skills, with the ability to influence and communicate cross-functionally across levels of seniority
- Proficient with Microsoft Office, including Word, Excel and Powerpoint
- Ability to work both effectively leading a team and working within a team
- High level of attention to detail and quality standards
DESIRABLE
- Relevant MSc, PhD or MBA or equivalent
- Formal project management qualification/certification
- Experience of working within a laboratory environment
About Us
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to 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 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.
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