Senior Clinical Project Manager
- Experience Level
- Experienced (non-manager)
AL Solutions is pleased to offer a fantastic opportunity to join a medium size award-winning CRO (Contract Research Organisation) with a global reach.
They are looking to hire an experienced Senior Project Manager to work home-based anywhere across Europe.
As they value the quality of their service, this is a flexible and trusting environment enabling you to set your own timeframes and deliverables and giving you the opportunity to work from the comfort of your own home.
They have experienced steady rapid growth over the last 3 years and are recognised as a company that focus on providing quality over quantity. You will be responsible for the overall coordination and management of clinical trials from start-up through to final delivery. This position directs the technical and operational aspects of clinical projects - all with the sense of urgency expected of the clients customers.
- Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
- Creates and executes project management plans required for project delivery and in accordance with established processes
- Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines.
- Establishes clear communication lines and escalation pathways, communicates with project stakeholders
- Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report
- Establishes requirements for and ensures project specific training plan for team activities
- Leads internal and external meetings, with internal and sponsor teams, including Kick-Off Meetings (KOM) and Investigator Meetings based on project scope
- Provides support for vendor identification, qualification and selection and manage vendors
- Manages vendors and vendor relationships as required for project delivery
- Ensures effective and efficient resource utilization across projects and programs
- Produces, maintains and circulates project progress and status reports
- Manages the study budget, including monthly invoicing.
- Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle
- Proactively recognizes and addresses any changes in scope
- Negotiates and influences internal and external team members in a professional manner and with successful outcomes
- Conducts review of initiation, monitoring and close-out visit reports
- May perform co-monitoring visits
- Ensures the Trial Master File is kept up to date and inspection ready
- Serves as the primary point of communication between the sponsor and project team
- Leads by example and encourages team members to develop strong solutions for clinical trial delivery
- Responsible for oversight of project team delivery and communication with functional managers, including performance feedback
- May be assigned as a line manager
- Minimum Bachelor’s degree in life science, healthcare and/or business degree
- Minimum 5 years of experience in drug development and/or clinical research, with at least 2 years of clinical trial project management experience
- Preference for candidates with CRA experience
- Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
- Demonstrates sound financial acumen, administrative excellence and strong analytical skills
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.alsolutions.co.uk or reach out to us via:
Tel: +44 (0) 203 778 0909
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