Clinical Team Lead - Medical Devices

Job Overview:

Clinical Team Lead - Medical Devices

Device Experience Preferred

 Responsible and accountable for the management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs. Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: Pre-Study Visits, Site Initiation Visits, Routine Monitoring Visit, Motivational Visits, Close-out Visits, Audit support Visits. Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines. Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol. Responsible and accountable for understanding and managing the clinical operations budget for the project, and ensure that the activities are within budget and scope of work, and to discuss with the project team to support financial progress, and team utilization. Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions. As required by the project roles participate and oversee the site selection process. Depending on the scope and roles within the project team, this may be performed in collaboration with other team members. As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking and documentation. Support new business with active participation in Bid Defense preparation and meetings, as required.

Perform other duties as required by the Department or Project Team. Education/Qualifications:BSc or BA degree in a biomedical or related life science, or nursing qualification Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job Experience:

Required:

 Minimum of five (5) years of relevant clinical research experience with an ability to demonstrate comprehensive understanding of: ICH/GCP guidelines; Serious Adverse Event (SAE) reporting, process production of reports, narratives  and follow up of SAEs; Site monitoring and study site management requirements; Applicable regional regulatory requirements; Trip report review, risk planning, study plan development, resource planning and data management oversight. In lieu of the above requirements, candidates with> two (2) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.

Additional requirements include:

  Demonstrated ability to work with minimal supervision. Demonstrated good planning and organization skills. Good computer skills with good working knowledge of a range of computer packages. Demonstrated effective and professional verbal and written communication skills. Ability to train, lead and develop junior staff. Ability to understand and work with financial information. Ability to resolve project-related problems and prioritizes workload for self and team. Ability to work collaboratively within a project team. Ability to work efficiently and effectively in a matrix environment.

Preferred: 1+ year's additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. Local project coordination and/or project management experience.