PEGlobal are looking for a Clinical Project Leader for their multinational medical devices client based in the West Yorkshire area on an initial 12 month contract.
This individual will be responsible for clinical project management within the company, as well as fostering strong, productive relationships with colleagues within the organization.
Serves 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 including, but not limited to, study planning, initiation, budget tracking, tracking and supporting subject recruitment, monitoring, quality of deliverables, site support and study closure. This role works closely with all parties involved in executing a clinical study.
Major Responsibilities of the role:
• 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.
- 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 probem 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.
- 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.
Desired Background and Experience of the successful candidate
- Minimum of a Bachelor’s Degree, preferably in a Life Science, Physical Science, Nursing, or Biological Science.
- 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.
- 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.
- Demonstrated competencies in the following areas are required:
- Written and verbal communications
- Presentation and influencing
- Organizational skills
- Ability to travel up to 50%.
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