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Clinical Project Manager - Contract - Yorks - UK

Operations
Ref: 362 Date Posted: Monday 10 Feb 2020
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JOB DESCRIPTION

 

Our Client an Orthopedic Test Laboratory provides critical testing services to the design and development of Orthopedic implants and instruments and operates within the orthopedic industry. Currently, they are looking to recruit a Clinical Project Leader to be responsible for clinical project management within the Company, as well as fostering strong, productive relationships with colleagues within the organization.

 

To serve as a member of the study core team and may serve as the liaison with the operating company for projects under his/her responsibility. Responsible for overall execution of small-medium regulated and non-regulated clinical projects or large non-regulated clinical projects (i.e.,250K USD Clinical Operations annual investment) including, but not limited to, study planning, initiation, budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure. May have personnel reporting to him/her within the scope of the clinical study. May have responsibility in a large clinical study managed by a CPM or Senior CPM. May provide support to department wide training.

 

This role works closely with all parties involved in executing a clinical study.

 

RESPONSIBILITIES:

 

People Leadership

  • Ensure that all Human Resource related activities and decisions embody the Company Values.
  • Provide leadership within a clinical study, ensuring that each Team Member has a well-defined set of activities and objectives specific to their role and responsibilities within the context of their business focus.
  • Ensure efficient use of resources within the clinical study to provide high quality deliverables.

 

Business Leadership

  • Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical projects.
  • May lead several small/medium clinical studies (regulated and non-regulated) and/or a small number of large non-regulated projects that may involve Clinical Research Associates (CRAs) and/or other clinical operations staff.
  • May assist with the management of large regulated studies under supervision of CPM or Senior CPM.
  • May support CPM and/or Senior CPM within a large or complex clinical study.
  • Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities.
  • Independently solve simple problems arising during clinical study execution, guidance required for move complex problem solving.
  • Manage all activities of assigned clinical studies within the Franchise Clinical Operations department.
  • Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
  • Understand business value and balance overall business objectives and functional needs.
  • May evaluate support requests for publications and provide consolidated comments and support to the requests.
  • May be involved in other tasks to support Clinical Operations and Operating Company as needed.
  • Manage Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency.
  • Track assigned projects budgets to ensure adherence to business plans.
  • Support the implementation of new clinical systems/processes.
  • Interface and collaborate with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel.

 

Administrative Leadership

  • Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance.
  • Provide quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies.
  • May provide training to employees or other individuals and/or group as needed.

 

QUALIFICATIONS:

Education

  • Minimum of a Bachelor’s Degree, preferably in a Life Science, Physical Science, Nursing, or Biological Science.

 

Experience

  • BS with at least 3 years of relevant experience preferred.
  • Previous experience in clinical study management or equivalent is required. Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
  • Clinical/medical background a plus.
  • Medical device experience a plus.

 

KEY ATTRIBUTES:

  • Requires basic skills in project management.
  • Requires understanding of Good Clinical Practices.
  • Understanding and application of regulations and standards applied in clinical areas is required.

 

COMPETENCIES

Demonstrated competencies in the following areas are required:

  • Leadership
  • Written and verbal communications
  • Presentation and influencing
  • Organizational skills
  • Ability to travel up to 50%.

Specialists in consultancy


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