Principal Clinical Team Lead - Homebased

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 12.0pt;">The Principal Clinical Team Lead (PCTL) is responsible and accountable for the driving the delivery of the clinical deliverable acting as the Clinical Project Manager role within the Core Team, as well as the portfolio team. The P CTL is expected to provide study and/or portfolio oversight of the clinical operations from a quality, timeline, budget and scope perspective. If needed for studies where combining the PM/CTL roles are feasible, the P CTL is capable of concurrently managing both Clinical and Project Delivery roles to ensure successful execution of the trial.  The P CTL must have the ability to lead multiple functions as a Project Lead as well as leading multiple levels of CTLs on a portfolio of large global trials.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong><span style="font-size: 16.0pt;">Essential Job Duties: </span></strong></p><ul><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Full oversight of a client portfolio for streamlined, efficient, high quality, consistent study delivery. </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Overall ownership of client-specific templates, SOPs, and guidance. </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Liaison for escalations within the clinical team which have an effect on deliverables. </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Responsible for clinical project delivery at the portfolio and/or project level with regards to agreed time, scope, cost and quality.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Accountable for leading clinical deliverables across the all functions for the assigned portfolio and/or studies.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Support/Lead Clinical project team ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Serve as escalation point for clinical project issues, within area of project responsibility, to internal and external stakeholders, as appropriate.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Serve as a key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Proactively identify and resolve conflicts across the entire portfolio as needed.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Understand the clinical project delivery strategy, costing assumptions and resulting budget for assigned project(s).</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Monitor clinical project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets. Initiate appropriate actions to proactively manage the change control process working in.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Proactively lead both quality control and risk assurance activities to ensure clinical project deliverables are met according to regulatory, Labcorp and client requirements.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Ensure successful creation and implementation of required clinical project plans. Monitor progress and manage variance to required clinical project plans and revise as necessary per SOPs. Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Track and maintain key clinical project performance indicators for specified client and internal metrics. Drive successful clinical team delivery on these KPIs/metrics.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Define and manage clinical project resource needs and establish succession plans for key resources.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">May act in a blended role between Project Management, Clinical Project Delivery and/or Start-up Project Management</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Perform other duties as required by the Department or Project Team</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">In collaboration with relevant departments, prepare and deliver presentations for new business as required.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Trains & mentors Sr.CTLs, CTLs, CRAs and IHCRAs in multiple areas of expertise.</span></li></ul><p style="margin-left: .25in;"><span style="font-size: 12.0pt;"> </span></p><p style="margin-left: .25in;"><strong><span style="font-size: 12.0pt;">Operational Delivery:</span></strong></p><ul><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Accountable for project delivery with regards to agreed time, scope, cost and quality</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Serve as a key client contact for assigned projects, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders. Depending on size and scope of project(s), this job duty may be performed in collaboration with a Project Director</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Serve as escalation point for project issues to internal and external stakeholders, as appropriate</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Proactively identify and resolve conflicts as needed</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Play an active role in understanding Root Cause for Quality Issues and help develop CAPA to be applied over entire portfolio. </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Take an active role in any major escalations to mitigate risk over the entire portfolio. </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s)</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Deliver project(s) to scope, schedule and costs, ensuring all remain on track with the contract and with financial performance targets. Initiate and implement appropriate actions to proactively manage the change control process both internally and externally</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Covance and client requirements</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Create and manage variance to required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary. Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs, providing performance feedback to team member’s respective supervisors</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Define and manage project resource needs and establish succession plans for key resources</span></li></ul><p style="margin-left: .25in;"><span style="font-size: 12.0pt;"> </span></p><p style="margin-left: .25in;"><strong><span style="font-size: 12.0pt;">Business Development:</span></strong></p><ul><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">In collaboration with relevant departments, prepare and deliver presentations for new business as required</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Partner with Delivery Directors to ensure an understanding of Sponsor pipelines, Book of Business Growth, in order to partner with key stakeholders in regards to resource planning and business expansion. </span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Perform other duties as assigned by management</span></li></ul><p style="margin-left: .25in;"><span style="font-size: 12.0pt;"> </span></p><p style="margin-left: .25in;"><strong><span style="font-size: 12.0pt;">Talent Development:</span></strong></p><ul><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Trains & mentors all functions supporting Clinical Delivery in multiple areas of expertise</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">May be responsible for Line Management and Talent Development</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Ensures allocated resources are aligned with current and forecasted work in terms of capability, quantity, timing, and efficiency</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">May be responsible for on-boarding, development and retention of high performing talent; strengthening and deepening talent bench and succession</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Assesses clinical project management competencies for assigned staff in order to create developmental plans that will increase competencies and close performance gaps</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Provides technical support to assigned project leaders, including training, development and performance review of assigned staff</span></li></ul><p style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;"> </span></p><p style="margin: 0px;"><strong><span style="font-size: 12.0pt;">Process Owner:</span></strong></p><ul><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Will support revising and developing processes for Global Clinical Project Delivery (GCPD)</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Expected to be an internal key contact for process questions impacting (GCPD)</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12.0pt;">University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)</span></li><li><span style="font-size: 12.0pt;">Fluent in English</span></li></ul><p style="margin: 0px;"><strong><span style="font-size: 12.0pt;">Preferred</span></strong></p><ul><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt;">Relevant Masters or other advanced degree</span></li><li><span style="font-size: 12.0pt;">PMP Certification</span></li></ul><p style="margin-left: .25in;"><span style="font-size: 12.0pt;">In lieu of the above requirement, candidates with seven (7) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered</span></p><h2>Experience:</h2><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong><span style="font-size: 12.0pt;">Minimum Required Experience: </span></strong></p><ul><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Six (6) years relevant clinical research experience in a pharmaceutical company/CRO, including at least three (3</span><span style="font-size: 12.0pt;">) years of CTL or equivalent combination of experience to successfully perform the responsibilities of the job.</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a heath care setting and (b) five (5) years clinical research experience including one (1) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Experience managing projects in a matrix and virtual environment</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Excellent communication, planning and organizational skills</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Demonstrated ability to lead by example and to encourage team members to seek solutions independently</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Demonstrated ability to handle multiple competing priorities and to utilize resources effectively</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Financial awareness and ability to actively utilize financial tracking systems</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Good knowledge of project management processes</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Ability to work independently and mentor junior project team members</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Ability to negotiate and liaise with clients in a professional manner</span></li><li style="margin: 0in 0in .0001pt .75in;"><span style="font-size: 12.0pt;">Ability to present to internal and external staff at all levels</span></li><li style="margin: 0in 0in .0001pt .75in;"> </li></ul><p style="margin: 0px;"><strong><span style="font-size: 12.0pt;">Preferred: </span></strong></p><ul><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt;">Prior portfolio oversight</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt;">Two (2) years of full project leadership or management responsibility</span></li><li style="margin-bottom: .0001pt;"><span style="font-size: 12.0pt;">PMP Certification</span></li></ul><p style="margin: 0px;"> </p>