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Senior Clinical Team Lead

Laboratory Corporation of America Holdings (Covance)

Mumbai, India

<h2>Job Overview:</h2><p style="margin: 0in 0in 0pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">The Senior Clinical Team Lead (CTL) is responsible and accountable for the execution of the clinical operations component of the project, at the global or regional level, as assigned. The Senior CTL is responsible for working cross functionally, within a matrix environment, to ensure successful execution of the trial including oversight of the clinical operations from a quality, timeline, budget and scope perspective. </span></p><p style="margin: 0in 0in 0pt;"> </p><ol><li style="color: #000000;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking and documentation</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Support new business with active participation in bid defense preparation and meetings, as required</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Perform other duties as required by the department or project team</span></li></ol><h2>Education/Qualifications:</h2><p style="margin: 0px;">Must have a Bachelor’s Degree (or equivalent).</p><h2>Experience:</h2><p style="margin: 0px;">8 – 10 years of relevant healthcare experience including minimum 5 -6  years of monitoring & site management experience, 0-4 years’ experience as a CPL.</p>

Job posted: 2021-10-20

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