A4P Consulting Ltd is a provider of bioanalytical and logistics expertise in scientific project management, contracted specialist services oversight and consultancy solutions to the global life sciences sector (see www.a4pbio.com for more detailed information).
Job Title: Clinical Biosample Operations Project Manager
|Job Purpose: The successful candidate will be responsible for ensuring strategic operational input into clinical laboratory testing of human biological specimens and the efficient operational deployment of such clinical laboratory testing at the programme level (including biomarkers, central safety testing and clinical bioanlysis for pharmacokinetic assessment).
· Provide appropriate operational contribution to the inclusion of laboratory testing of human biological specimens into clinical programmes and trials
· Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of clinical biosamples (including companion diagnostic samples) – collection, processing, analysis, data delivery process and final sample disposition
· Ensure all the laboratory components within planning operational delivery documents are accurate and fit for purpose. Ensuring strategy for the sampling plan is deployed and lessons learnt are communicated to the study level personnel to ensure optimal synergies of activities for study level activities in assigned projects
· Collaboration with Biomarker scientists as well as operational teams, diagnostic partners, external CRO & Central Labs, and biomarker vendors to execute the biosample operational strategies on one or multiple studies/projects
· Management of the development and oversight of the biosample analysis timelines, budget, risk and quality plans
· Oversee delivery of laboratory services and data from external providers at a project level.
· Provide rapid, regular and frequent updates of all activities to the clinical study teams.
· Contribute to ongoing development of A4P products and services
· This list is not exhaustive and other tasks in line with the role might be assigned
Job Location: Required to be present at two locations. The times at each location will vary dependent upon A4P’s and the clients needs and requirements. Remote working may be considered as an alternate to relocation to East Kent. Nevertheless, there will be an expectation that the successful candidate will be required to visit the Sandwich site at least on a monthly basis for at least two consecutive days
1. A4P Consulting Ltd, Innovation House, Discovery Park, Sandwich, Kent, UK
2. Major Pharmaceutical Company R&D site in mainland EU (Germany, Switzerland)
|Education and Experience
· Proven experience in clinical development and operational deployment of biological assays obtained in a major pharmaceutical company or large CRO organisation within a project management role is required.
· Proven experience in oversight of external partners, laboratory service providers is required.
· Biological laboratory experience and biomarker scientific background is desirable.
Engaging, enthusiastic, self-motivated, confident, self-assured and a team player. Willing to interact with large organizations on behalf of a small company
· Demonstrable ability to prioritize activities with strong attention to detail and effectively multi-task across deliverables
· Excellent communication skills in both written and oral areas. Strong presenting skills
· Gain client trust and confidence in A4P abilities to deliver clients objectives and requirements
· Willingness and availability to travel and work at client’s site(s) for short periods of time.
· Willingness and availability to travel and work at A4P’s location in Sandwich, Kent on regular (frequency negotiable) basis for duration of employment.
· Demonstrable significant understanding of the research activities undertaken within a drug development organization
· Ability to develop effective relationships with external service partners
· Full driving licence may be advantageous though not essential
Hours of Work: This position is a full-time role based on 37.5 hrs. per week, excluding lunch & holidays with an initial 3-month probationary period. A4P operates a degree of informal flexibility as regards working hours attendance.