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Clinical Project Manager

  1. United States
2023-99348
  1. Project Management
  2. ICON Strategic Solutions

About the role

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ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

 

ICON Government and Public Health Solutions (IGP) is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.

 

IGP is seeking a Senior/Project Manager to be responsible for the overall coordination, implementation and completion of regional/global cross functional projects including consistency with ICON SOPs, study contracts and budgets. To provide expert project management input into new business proposals and bid defense meetings.


Senior Project Manager:

 

  1. Recognize, exemplify, and adhere to ICON'S values, which centers on our commitment to People, Clients and Performance.
  2. As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  3. Travel (approximately 10%} domestic and/or international
  4. Primary point of contact for designated complex, cross-functional regional and/or global projects and responsible for developing successful working relationships with clients, and ensure repeat business return to ICON
  5. Responsible for project planning, scheduling, and implementation. Define project scope, resource requirements and deliverables develop and maintain cross-functional project management plans
  6. Responsible for risk mitigation strategies, associated action plan and issue resolution
  7. Responsible for managing cross functional project team including ensuring all necessary project trailing is provided to assigned staff
  8. Provide direction and support to project team
  9. Manage projects in accordance with the contract including
  10. Proactively manage any study budget including changes in scope
  11. Collaborate with Business Development (80) to ensure timely execution of change orders
  12. Managing study invoicing procedure’s
  13. Track Project deliverables using appropriate tools
  14. Effectively monitor and report on progress of the project to all stakeholders
  15. Implement QC activities as necessary and monitor required quality memos
  16. Develop a succession plan for core team members and in the event of a change to the team, ensure an effective hand-over
  17. Mentoring and training relevant project personnel as appropriate
  18. Participate online in the interview process as necessary
  19. Maintain confidentiality of management information, as appropriate
  20. Participate in business development activities including bid offense and proposal activities
  21. Participate in Company initiatives as requested
  22. Manage Administrative Assistants as assigned
  23. Manage additional project resources as required
  24. Manage employees who are assigned as required
  25. Other duties as assigned

 

Project Manager:

  1. Recognize, exemplify, and adhere to ICON's values, which center on our commitment to People, Clients, and Performance.
  2. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  3. Travel (approximately 10%) domestic and/or international. Travel to other sites within the network may be required to support increases in workload and, or studies/projects as needed.
  4. Lead the planning and implementation of cross- functional project(s).
  5. Facilitate the definition of project scope, goals, and deliverables
  6. Define project tasks and resource requirements.
  7. Develop full-scale cross-functional project plans.
  8. Assemble and coordinate project staff
  9. Manage project budget
  10. Plan and schedule project timelines
  11. Develop and Manage Risk Mitigation Strategies for projects
  12. Track project deliverables using appropriate tools
  13. Provide direction and support to project team
  14. Quality assurance
  15. Constantly monitor and report on progress of the project to all stakeholders
  16. Present reports defining project progress, problems, and solutions
  17. Implement and manage project changes and interventions to achieve project outputs
  18. Project evaluations and assessment of results
  19. Manage Administrative Assistants and/or Project related assistants as assigned

 


Senior Project Manager: 10+ years of experience in clinical research, or at least 7 years of experience in clinical research when combined with 3 years or more of project management experience.

 

Project Manager: 7+ years of experience in clinical research, or at least 5 years of experience in clinical research when combined with 2 years or more of project management experience.

 

  • BA/BS degree in a scientific/business field, with sufficient work experience in clinical research.
  • Must show demonstrated skills in Project Management, Leadership, Risk Management, and Decision Making. Qualification in a Project Management or equivalent (PMI certification is desirable.)
  • Possess the ability to organize, instruct and supervise staff, while promoting group effort and achievement.
  • Ability to identify issues, track progress, and follow through on actions to meet customer satisfaction.
  • Must have CRO or pharma experience.
  • Skilled in communicating issues, impacts, and corrective actions to varying levels of corporate personnel and customer leadership personnel.
  • Excellent written, verbal, and interpersonal communication skills, organizational skills and a great attention to detail are required. Must be able to work as a member of a team and possess good problem-solving skills
  • Possesses thorough knowledge of the Good Clinical Practice (GCP) guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials
  • Must be able to work independently following a brief period of specific technical training.
  • Ability and willingness to travel up to 10% including globally

 

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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