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Senior Clinical Project Manager

Job Title: Senior Clinical Project Manager
Location: Bridgend
Department: Clinical Project Management
Reporting to: Head of Clinical Project Management
Responsible for (staff): N/A

General Purpose of Role:

  • To be a subject matter expert (SME) in one or more of the various service offerings for PCI Bridgend. To lead and manage client projects and various stakeholders (including the Sponsor, CRO, Depot and internal departments) from the hand over phase to project close down to ensure all deliverables are met according to timelines, budget, quality and operational standards.

Main Responsibilities:

  • To represent PCI as a Subject Matter Expert (SME) both internally and externally with clients and at events and conferences in one or more of the various service offerings for PCI Bridgend.
  • To support other members of the clinical project management team with projects where their expertise is required.
  • To keep ahead of industry changes and updates within their SME area(s) for PCI Bridgend.
  • To manage all aspects of the study from hand-over to close-down activities to agreed timelines and budget in accordance with cGMP and cGDP.
  • To support Business Development in the scoping of proposals for Key clients and maximising opportunities for PCI to win further studies by developing client relations.
  • To ensure that every project is adequately handed over from Business Development to Project Management and relevant Operational, Quality and Technical personnel.
  • To design study supplies according to study protocol and client requirements and liaising with relevant internal PCI depts. and external approved suppliers as required as part of the process. This includes reviewing study supply design as part of the distribution activities.
  • To initiate a Project Plan at point of handover (using MS Project) that is maintained as a ‘live and working’ document and shared with the Client and internal departments.
  • To support and work in a cooperative manner with the internal PCI depts. (such as the Project Set Up team, Operations and Quality) to provide the necessary information to prepare operational documentation to the required standards and timelines to deliver the project.
  • To set up and manage distribution depots according to study and client requirements to deliver the project.
  • To interact with IRT systems according to study and client requirements to deliver the project.
  • Proactive involvement in Quality Events and responsibility for communicating with the Client.
  • To provide up-front visibility to the operational team for packaging, labelling, storage and shipping requirements. Including forecasting usage of temperature monitors and validated shipping systems.
  • Ownership and responsibility for invoicing for completed project activities and updating the anticipated monthly / quarterly / yearly budget revenue to agreed metrics.
  • Responsible for maintenance of the forward order book on assigned projects, ensuring its timely completion and accuracy within the agreed metrics.
  • Preparation and provision of project documentation required as part of the Product Specification File and or Project File, such as Project Specification, Master Works Orders, Master labels, etc. in-line with agreed operational capabilities. This includes providing PCI documentation to the Client for approval as required, or obtaining documentation from the Client as needed.
  • Provision of internal and Client reports as required (for example, budget vs actual reports, reports agreed with the client in the proposal, KPI reports on distribution).
  • To highlight and scope out the requirements for any additional work on a study ‘Change Order’ (in advance of it being required) with the Client and Business Development.
  • To ensure that all studies are efficiently closed-down to the agreed procedures.
  • To support the department head in the development and improvement of internal project management systems/processes as required to meet the needs of the business.
  • To attend client teleconferences, meetings, conferences and events as required.
  • To undertake specific projects as and when required within the scope of the job holders responsibilities and capabilities.
  • To accurately record weekly project management time spent on specific projects according to Company requirements.
  • Comply with company policies, procedures and behaviours.
  • Working in a safe manner at all times and highlighting any safety issues to an appropriate person as soon as possible.

Outcomes of Role:

  • To keep ahead of industry changes and updates within their SME area(s) for PCI Bridgend.
  • The on-time, on-budget delivery of client projects to relevant standards.
  • Reporting of Project Management metrics and KPI statistics as required and to support Business Review Meetings.
  • Provision of visibility of goods receipts, packaging, labelling, storage and shipping requirements for all projects to internal departments.
  • The active participation in improvements to departmental and cross company procedures and systems.

Specific Qualifications:

  • Preferably qualified in a scientific discipline (degree, HNC or equivalent).

Specific Knowledge / Skills Competence:

  • Experience in a client facing role, preferably in the clinical supply field and a contract environment.
  • Clear and concise presenter to internal/external customers
  • Proficient in the use of Sage 200 and MS Office Packages
  • An excellent understanding of Quality Standards including GMP, GCP and GDP. Familiar with concepts of risk management.
  • Experience in managing projects, change and growth.
  • Excellent written and verbal communication; structures communication in a logical way. Matches influencing style to the person and/or situation and secures positive outcomes through negotiation.
  • Experienced and up to date in the subject matter for which they specialise whilst having an understanding of the technical principles in other areas of the business.

Behavioural Competencies:

  • Accountability
    • Demonstrates a determination to succeed and is able to ‘push’ to make things happen
    • Is able to multi-task and handle projects at the same time whilst adjusting to changing priorities
    • Motivated, self starter, able to work without supervision on own initiative but is also a team player.
    • Understands consequences of their own actions to the business or industry
    • Considers all available facts before reaching a conclusion
  • Enterprise
    • Considers all relevant factors impacting projects
    • Thinks things through strategically and explores the benefits to the businessDemonstrates business acumen and plans the financial aspects e.g. costs of people, material etc.
  • Team;
    • Develops positive working relationships with customers and colleagues at all levels
  • Customer Focus
    • Critically evaluates progress / potential problems and implements corrective action where necessary
    • Is able to perform under pressure, remaining calm and objective throughout
    • Is able to identify dangers and opportunities at an early stage
Posted on Categories EU, EU Bridgend, Vacancies

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