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Senior Clinical Project Manager - UK - Oncology focused, growing CRO

Employer
Upsilon Global
Location
UK
Salary
Competitive
Closing date
18 Apr 2021

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Sector
Healthcare
Contract Type
Permanent
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Job Details

Upsilon Global are seeking an experienced Senior Clinical Project Manager to come on board with one of our partners; an exciting UK based CRO who's primary focuses are across oncology, rare diseases, and advanced cell & gene therapies. Since their formation in the early 2010s they have been able to rapidly expand in to the successful niche CRO they are today with upwards of 50 employees.

In partnering with life science companies, they transform promising molecules into valued medicines while ensuring early clinical development strategies are optimised and that Phase I/II studies are both innovatively designed and expertly delivered.

The Clinical Project Manager is responsible for planning and implementing the team objectives for clinical trials and delivering to time and budget. You will plan and manage the clinical trials in order to ensure the safe, effective and efficient delivery of all operational aspects of studies through all phases of study management in accordance with appropriate quality standards. You'll be accountable for the development, project management and delivery of site management plans and will work closely with clients and colleagues within the business in order to understand the requirements and deliver against these successfully.

Key responsibilities
  • Develop the initial scope of work for clinical projects, working with the client and the in house team to clearly define the requirements, project costs/budget and resources
  • Develop a quality management plan and associated risk log for all projects
  • Lead the resourcing of study teams and the study site set up, contributing to the study feasibility, site selection, resource plan and driving the first subject in, ongoing recruitment, risk management and study delivery plan
  • Lead the site management activities including the development and management of regulatory documentation, scheduling and management of all site visits in line with the agreed client contract requirements
  • Proactively interface with the in housel team and the client in order to manage the project and develop solutions to issues and challenges which arise
  • Provide clinical operational expertise for the local study team and ensure compliance at all times with company governance guidelines
  • Coordinate the daily operations of the in house team, including definition of the project timelines with the assigned study team, coordination of the remote review of clinical data, review and approval of trip reports and follow up, management of project meetings and ensuring the provision of required training for the CRAs
  • Manage the delivery of study milestones and patient recruitment targets by the team proactively addressing deficiencies/deviations
  • Manage all project resources, including conducting regular reviews of budgets, ongoing monitoring of costs and potential overruns and the implementation of proposals for cost-effective solutions/mitigation strategies as required
  • Ensure any potential out of scope activities are tracked and discussed with the Contracts and Proposal Manager on a monthly basis
  • Work with the Associate Director for Clinical Operations to define and manage the performance of the CRA's and CTA's as required, providing coaching and supporting the development of clear expectations and goals to ensure team performance overall is fully optimised
  • Ensure all project documentation is managed appropriately and prepare for audit responses as required. Prepare weekly/monthly report information for the clients
  • Develop and maintain strong, positive relationships with clients and key internal stakeholders to clearly understand the business processes and the short and long term business objectives
  • Support CRAs in site data collection and locking, query resolution, progress to data base lock
  • Support CRAs or if necessary personally undertake study start up activities by obtaining documents for drug release and ensuring site documentation is correct
  • Participate in the analysis, summary and reporting of clinical data for regulatory or market purposes as required
  • Collaborate in the preparation of quality/compliance reviews, internal audits and regulatory inspections and ensure adequate and timely CAPA follow up
  • Identify areas of best practice and contribute to activities to improve and maintain the quality and effectiveness of processes and activities across the teams
  • Maintain knowledge of all relevant clinical processes and SOPs to ensure appropriate compliance to ICH-GCP and ABPI code of practice
  • Organise, conduct and report local quality control activities with CRAs (e.g. accompanied visits, review of monitoring visit reports, review of monitoring quality, review of SMF and ISF documents and key system checks)
  • Manage and control allocated budget spend for the areas of responsibilities within this role
  • Develop, implement and maintain company policies for which you are the named Subject Matter Expert
  • Contribute to proposal generation and participation in bid defence meetings

Minimum requirements
  • Degree or equivalent qualification
  • Advanced knowledge of good clinical practice and understanding of local Competent Authority regulations is required; international clinical trial experience and knowledge of other country requirements is preferred
  • A minimum of 8 years of clinical project management experience
  • A minimum of 5 years of oncology studies experience
  • Global study/project management experience is preferred
  • Proven ability to influence and manage both clients and investigators.
  • Ability to lead and influence in a fast paced and collaborative environment
  • Excellent interpersonal, negotiation and conflict resolution skills
  • Proven ability to lead projects and motivate at all levels
  • Ability to manage and develop others
  • Ability to work within and lead teams
  • Ability to contract with others
  • Ability to build teams and bring stakeholders together
  • Ability to lead and facilitate groups and workshops
  • Can operate on the big picture as well as with detail
  • Excellent presentation skills, with solid oral and written communication capabilities
  • Strong technical skills using PowerPoint, Excel and Word

Please contact Harry Henson on harry.henson@upsilonglobal.com or +44 203 875 99 66 for further information about this vacancy.
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