Centralized Start-up Lead, Sta

<h2>Job Overview:</h2><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt;">Primarily oversees and manages amendment phase of domestic and/or international clinical trials.  Where required, may also take on start-up tasks under the direction of a Project Manager, Start-up.  Responsibilities include project managing defined study activities within timelines, scope, quality and budget, ensuring that client’s expectations are met. </span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt;">GENERAL:</span></p><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Lead the team through the amendment phase of a study. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Responsibilities may also include activating sites in active start-up</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Serve as primary client contact with autonomy to interact directly with the client on a broad range of contract amendment issues and decisions</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Monitor and control project schedule. </span><span style="font-size: 11.5pt;">Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. </span></li></ul><p style="margin: 0px;"><em><span style="font-size: 11.0pt;"> </span></em></p><p style="margin: 0px;"><strong><span style="font-size: 11.5pt;">FINANCE MANAGEMENT </span></strong></p><ul><li style="margin: 0in 0in 2.35pt .5in;"><span style="font-size: 11.5pt;">Ensure that work is performed within budget. Interpret billing guidelines for the functional area/region and schedule training for start-up team accordingly </span></li><li style="margin: 0in 0in 2.35pt .5in;"><span style="font-size: 11.5pt;">Proactively identify risk of over-spend and track project progress against financial milestones using applicable financial systems. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.5pt;">Implement and follow pre-approved procedures for write off or budget overages. </span></li></ul><p style="margin: 0px;"><em> </em></p><p style="margin: 0px;"><strong><span style="font-size: 11.5pt;">RESOURCE MANAGEMENT </span></strong></p><ul><li style="margin: 0in 0in 8.35pt .5in;"><span style="font-size: 11.5pt;">Determine needs, request, and independently manage project start-up resources. Adapt/request resources as applicable to ensure project deliverables are met. </span></li><li style="margin: 0in 0in 8.35pt .5in;"><span style="font-size: 11.5pt;">Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.5pt;">Identify and escalate non-compliance related to maintaining professional standards, following processes and SOPs to respective line managers and/or QA.</span></li><li style="margin-left: .5in;"><span style="font-size: 11.5pt;">Provide performance feedback of team members to respective line managers and project management team. </span></li></ul><p style="margin-left: .25in;"><strong><span style="font-size: 11.5pt;"> </span></strong></p><p style="margin-left: .25in;"><strong><span style="font-size: 11.5pt;">JOB SPECIFICS </span></strong></p><ul style="margin-top: 0in;"><li style="margin-bottom: .0001pt;">Develop an amendment submission and approval strategy in conjunction with the Project Lead, other functional groups and the client to ensure amendment deliverables are completed within agreed project timelines and in accordance with client’s expectations</li><li style="margin-bottom: .0001pt;">Proactively manage amendment progress, expectations and deliverables</li><li style="margin-bottom: .0001pt;">Understand client expectations for deliverables/milestones, and liaise with applicable functional teams in creation and modification of site activation timelines throughout the lifecycle of the project</li><li style="margin-bottom: .0001pt;">Oversee preparation of amendment submission including but not limited to ICF updates/review/approval and other necessary documents</li><li style="margin-bottom: .0001pt;">Oversee ethics and regulatory bodies submission and approval status. Coordinate addressing queries ensuring required timelines are met</li><li style="margin-bottom: .0001pt;">Contribute to a Start-Up Plan if required, overseeing Investigator Package compilation, green light approval and contributing to a cross functional team ensuring that sites achieve Ready to Enroll status on time</li></ul><ul><li style="margin: 0in 0in 8.35pt .5in;"><span style="font-size: 11.5pt;">Review and provide input to core study documents, as applicable. </span></li><li style="margin-left: .5in;"><span style="font-size: 11.5pt;">Present at external and internal meetings including, but not limited to: project core team and client meetings.</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.5pt;"> </span></p><p style="margin: 0px;"><strong><span style="font-size: 11.5pt;">COVANCE LEADERSHIP OVERSIGHT/QUALITY ASSURANCE</span></strong></p><p style="margin: 0px;"> </p><ul><li style="margin: 0in 0in 8.35pt .5in;"><span style="font-size: 11.5pt;">Responsible for appropriate issue escalation to QA Triage and/or appropriate stakeholder(s). </span></li><li style="margin-left: .5in;"><span style="font-size: 11.5pt;">Support audits (internal and external) and inspections, as needed. Support resolution of any findings. </span></li></ul><p style="margin: 0px;"><strong><span style="font-size: 11.5pt;">OTHER </span></strong></p><ul><li style="margin-left: .5in;"><span style="font-size: 11.5pt;">Perform other duties as assigned by management.</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered</span></p><h2>Experience:</h2><h2><span style="font-size: 10pt;">Minimum Required:</span></h2><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Four (4) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), including demonstrated skills and competency in study start-up and/or amendment management.</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Preferably local project coordination and/or project management experience</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;"> </span></p><p style="margin: 0in; margin-bottom: .0001pt;"><u><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Required </span></u></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Undertaken similar activities in > 1 country for more than 6 months</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Direct Sponsor contact</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;"> </span></p><p style="margin: 0in; margin-bottom: .0001pt;"><u><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Preferred</span></u></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Experience in oversight of start-up activities</span></p><p style="margin: 0in; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Experience outside of region</span></p>