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Role Filled
Project Manager
Scientific Supplier
Internal Technical Support
Cambridge
£50,000 - £60,000
Genomics/NGS/Sanger sequencing/RT-PCR/qPCR
Role Overview
We are looking for an experienced Project Manager to join the Business Development function. This role is very hands-on and will be managing projects across Cambridge and beyond. You will be responsible for project managing complex cross functional teams to deliver high quality products, many of them IVDs, to our customers These will play an important part in driving improvements in our understanding of genetic diseases and the goal of ultimately improving patient care.
Role Requirements
Your duties will include:
Work closely with R&D, Marketing, Quality/Regulatory, Medical Affairs and Production on the planning and execution of diagnostic development projects and product/process change projects
Lead cross-functional project teams to deliver projects to agreed scope, cost, quality and timeline
Organise and lead regular project team meetings ensuring timely completion of tasks
Analyse, plan and track project activities, communicating progress against plan on a regular basis to all relevant stakeholders, including maintaining decision logs, meeting minutes, timelines and shared documentation
Ensure programme governance process is adhered to with formal documentation and reporting
In conjunction with key stakeholders ensure project files are maintained to support the quality management system, particularly for the Quality System Regulation requirements of 21 CFR 820 and ISO 13485
Identify and efficiently resolve or escalate issues and risks to stakeholders in a timely and clear fashion
In conjunction with relevant stakeholders identify resources required and manage these for all projects. With Head of PMO, manage resourcing, dependencies and interfaces between projects.
Track estimated project costs and proactively communicating deviations to relevant stakeholders
Apply project management tools and methodologies to ensure cross-functional alignment and accountability
Develop positive relationships with internal teams and stakeholders
Work with internal teams to ensure smooth transition to business as usual as the projects conclude and conduct lessons learned evaluations and guidance at the point of handover
Evaluate and propose activities and interventions where innovation or best practice becomes an opportunity for improvement within budget and agreed timelines.
Person Specifications
Qualifications
– BSc and MSc or other post-graduate level qualification in life or medical sciences
– Experience and expertise
– Strong scientific knowledge and good understanding of genomics and genetic diagnostics
– Good understanding of Project Management principles, concepts, practices and standards
– Managing diagnostic development projects in either the pharmaceutical or diagnostic industry
– Managing new product development processes within ISO 13485 as well as 21CFR 820 compliant quality systems
– Experience of development of IVDD/IVDR products, particularly experience with FDA Pre-Market Approvals (PMA) and Notifications (510(k))
– Managing project level budgeting, contracting and financial controls
Skills
– Strong presentational skills, including communicating to senior stakeholders internally and externally
– Ability to create and lead highly motivated cross functional teams to deliver successful projects
– Building trusted, influential relationships with senior stakeholders that facilitate effective decision making and project execution
– Strong analytical skills with a proven ability to balance and prioritize responsibilities in accordance with business and team needs
– Engaging with technical teams to ensure effective solutions to design and development challenges
– Maintain team focus on quality while adhering to project timelines and goals
– Confident user of digital project and team management tools for planning, communication, activity tracking and reporting.
Desirable
– Certification of competence in a recognised project management framework e.g. PMP
– Experience of clinical trials of pharmaceutical products would be advantageous.
Package
£50K – £60k
Pension Scheme (10% non-contributory)
Private Health Insurance
Private Dental Insurance
Group Income Protection
Group Life Assurance
25 days holiday plus UK bank holidays
High Street Discount Scheme.
Locations
Banbury
Bicester
Oxford
Witney
Previous Listing
Date Updated
26 Jan 2024
Job reference
72270
Categories
Full Time
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