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PM II/ Sr. Project Manager - General Medicine - remote

Employer
Premier Research
Location
United Kingdom
Salary
Competitive salary
Closing date
11 Feb 2022

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Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Function
Project Manager, Senior Project Manager
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Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Project Manager II/ Sr. Project Manager to bring your passion to our General Medicine team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world. 

At Premier Research, we are science-minded and heart-centered. Join us.
 

You'll be doing: 

  • Ensures successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
  • Ensures adherence to project budget and scope of work to realize project profitability
  • Ensures all project tasks are completed in accordance with project plans and in compliance with standard Premier Research processes, policies and procedures
  • Ensures effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally
  • Ensures compliance for project-related training
  • Ensures adequate resourcing is available to meet project deliverables and milestones
  1. For project success:
  • Chairs internal project team meetings and teleconferences
  • Manages the project team to ensure study progress is according to both client and Premier Research requirements
  • Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
  • Develops, prepares, and executes project plans for all phases of the project lifecycle, including quality, risk management and proactive contingency plans, ensuring that issue escalation and resolution is clear
  • Reviews and approves project plans developed by the functional leads
  • Facilitates proactive communication across the project team and departments
  • Maintains and evaluates study progress by using company tracking systems, project timelines and budget reviews
  • Provides project progress reports including performance against contract, customer expectations, and project baselines to internal and external stakeholders
  • Monitors timelines and clearly communicates timeline changes both internally and externally as applicable
  • Monitors the quality of project deliverables and addresses quality issues with the appropriate team members
  • Troubleshoots and facilitates the resolution of project related conflicts with necessary corrective and preventative actions, delegates as needed, and escalates potential issues appropriately to relevant stakeholders
  • Continually reviews and makes recommendations to ensure adequate resources are available to meet project deliverables and milestones
  • Manages assigned resources, including assigning project tasks to correct staff and vendor
  • Ensures all necessary roles on project are filled
  • Ensures appropriate functional lead roles are filled and ensure accountability in functional lead roles
  • Oversees project documentation, ensuring Trial Master Files are completed by the functional groups and audit ready
  • Creates and implements project documents and tools
  • Supports study audits and responds to audit reports
  1. For commercial success:
  • Monitors and manages customer satisfaction
  • Prepares forecasts for staff utilization over the life of the study
  • Reviews and approves project expenses and ensures all study related contractual and budgeting issues are addressed
  • Provides accurate information to ensure timely invoicing and allow for accurate forecasting
  • Identifies and manages scope of work, including recognizing and negotiating changes across all functional areas and securing Change Orders
  • Assists in Business Development activities, including leading proposal presentations in partnership with Business Development and Strategic Drug Development
  • Develops strong relationships with current clients to generate new and/or add-on business for the future
  • Makes strategic suggestions to customers for change in approach, often anticipating a need
  • Ensures appropriate transition planning and stakeholder communication for any change in staff
  • Collaborates with client's senior-level and project team personnel
  • Leads/facilitates internal and external project meetings through the life cycle of the project
  • Presents at Investigator Meetings
  • Communicates ideas clearly when speaking in front of large and small audiences
  • Communicates project progress clearly, to appropriate audiences
  • Negotiates win/win solutions with superiors of internal/external customers
  • Understands the needs of the customer and the project
  • Leads customers and stakeholders to understand when needs and wants don't match
  • Contributes to RFI/RFP requests
  • Identifies, recruits and manages central vendors as required per project scope

You'll need: 

  • Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
  • 6 years relevant experience, preferably in a pharmaceutical company/medical device company/CRO including 2 years of clinical project management or clinical management experience
  • 3 years of experience in managing progressively large and complex scientific research projects, at least half of which has been in a matrix environment
  • Served as a Project Manager for one or more small/non-complex projects
  • Strong budget/finance experience on a project level
  • Strong therapeutic and protocol knowledge
  • Strong knowledge of ICH/GCP regulations
  • Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
  • Strong knowledge of the principles of project management
  • Strong knowledge of the clinical development process
  • Good understanding of full-service functional areas
  • Knowledge of web-based communication tools for conferences
  • Highly confident and effective presenter
  • Strong software and computer skills, including MS Office applications
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