Clinical Project Manager

Job Description: P1vital Products Ltd Operations
Title: Clinical Project Manager
Position type: Permanent, Full time
Location: Wallingford or Home based, UK travel will be required
Reports to: Director of Operations

Role and Responsibilities:
P1vital Products Ltd (PPL) is an established SME specialising in the development of software products for the pharmaceutical and healthcare sectors, with a recognised pedigree in mental health. The Clinical Project Manager role is a senior position within PPL responsible for the overall relationship management of client accounts and day to day project management, clinical operations and communication activities, to ensure that PPL is able to deliver quality projects and services on time and within budget through effective management of resources.

Key responsibilities of this role comprise:

Project Management
– Manage one or more PPL projects with a focus on delivery to time, within budget and with a highquality outcome
– Track all study deliverables, monitor project progress against scope, milestone timelines and budget, and quality standards, and track critical issues and/or risks; as required, ensure necessary corrective actions are taken to secure timely resolution
– Monitor project financials, budget tracking and accuracy of invoicing
– Personnel management and mentorship of Junior Project Manager

Clinical Operations
– Ensure clinical trials are run in accordance with relevant regulatory standards, ICH GCP, PPL and client SOPs
– Coordinate and oversee feasibility assessments and site selection for our clinical trials
– Prepare study ethics, R&D, regulatory and site-specific submission packages as required, address queries raised relating to these submissions, and ensure approvals are in place prior to study start
– Coordinate and oversee the set up and population of study files within PPL and at clinical study sites
– Develop and maintain key study documentation including informed consent forms, case report forms etc.
– Manage the internal study team and study subcontractors including investigator site facilities and
staff, central laboratories, etc
– Manage and oversee study recruitment including the development and maintenance of strong working relationships with site investigators and study site staff to promote effective study recruitment strategies
– Conduct study monitoring, co-monitoring and other data checking activities and/or oversee CRAs performing such activities
– Identify training and/or process issues at study sites, and provide corrective solution
– Provide operational advice and guidance on studies being conducted
– Produce study reports on a regular, study-interim or study-end basis, as required
– Contribute to discussions with clients regarding clinical operations for prospective new projects
– Author and/or review company SOPs and guidelines as required

Communications
– Lead client meetings and manage client expectations in line with PPL’s capabilities
– Lead internal project meetings, capturing minutes / action items
– Conduct regular study meetings with Site Investigator teams
– Represent PPL at investigator meetings
– Provide pro-active communication with all stakeholders

Skills and experience:
Essential Competencies
– Excellent communication and presentation skills (both written and oral)
– Strong project management skills
– Advanced organisational, time management, administrative, and computer skills e.g. MS Project, Excel, Word, PowerPoint
– Strong concern for quality, attention to detail and accuracy
– Ability to establish and maintain effective working relationships with colleagues, managers and clients, with ability to manage and motivate others
– Ability to deliver results to the appropriate quality and timeline metrics
– Ability to multi-task, problem solve, and to work independently in a fast-paced environment
– Ability to travel to clinical site destinations (UK, EU)
– Proactive contribution to PPL by being a versatile and flexible team player

Experience
– Bachelor’s (and/or higher) degree in Life Sciences or a related scientific field
– Project Management and Clinical Operations experience essential
– Minimum of 5 years’ experience as a Clinical Project Manager preferred
– In depth knowledge of ICH-GCP essential
– Prior experience of managing multi-centre Phase 1 and 2 studies within the pharmaceutical, biotechnology or medical device sectors preferred
– Understanding of SaaS technology in clinical research desirable
– Experience of managing small teams in a project based environment desirable

If you are interested in applying for this role please email your CV with a cover letter to recruitment@p1vital.com.