Clinical Team Lead - Medical Device

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12pt;">Clinical Team Lead - Medical Device</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 12pt;">Home Based anywhere in the US or Canada</span></p><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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. </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking and documentation.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Support new business with active participation in Bid Defense preparation and meetings, as required.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Perform other duties as required by the Department or Project Team.</span></li></ul><h2>Education/Qualifications:</h2><ul style="margin-top: 0in;"><li><span style="font-size: 11.0pt;">BSc or BA degree in a biomedical or related life science, or nursing qualification</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job</span></li></ul><h2>Experience:</h2><h2><span style="font-size: 10pt; font-family: verdana, geneva;">Minimum Required:</span></h2><h2 style="margin-left: .5in;"><span style="font-size: 10pt; font-family: verdana, geneva;">·    0-4 years’ experience as a CTL, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.</span></h2><ul style="margin-top: 0in;"><li><span style="font-size: 10pt; font-family: verdana, geneva;">Minimum 4+ years CRA experience, on-site or in-house.</span></li></ul><p style="margin-left: .5in;"><span style="font-size: 10pt; font-family: verdana, geneva;">Or</span></p><h2 style="margin-left: .5in;"><span style="font-size: 10pt; font-family: verdana, geneva;">·       In lieu of the above minimum requirement, candidates with 6 or more years of relevant clinical research experience in pharmaceutical, CRO or health care setting will be considered.</span></h2>