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Associate Manager, Clinical

Laboratory Corporation of America Holdings (Covance)

Sydney, Australia

<h2>Job Overview:</h2><p style="margin: 0cm; margin-bottom: .0001pt;">Join Labcorp and our FSPx department, sponsor dedicated.</p><p style="margin: 0cm; margin-bottom: .0001pt;"> </p><p style="margin: 0cm; margin-bottom: .0001pt;"><strong>We are looking for an Associate Manager Clinical Research to be based in Sydney.</strong></p><p style="margin: 0cm; margin-bottom: .0001pt;"> </p><p style="margin: 0cm; margin-bottom: .0001pt;">This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. <br /><br /><strong>Responsibilities include, but are not limited to:</strong></p><p style="margin: 0cm; margin-bottom: .0001pt;"><br />• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.</p><p style="margin: 0cm; margin-bottom: .0001pt;">o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.</p><p style="margin: 0cm; margin-bottom: .0001pt;">o Performs Quality control visits as required</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Responsible for creating and executing a local risk management plan for assigned studies</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Ensures compliance with CTMS, eTMF and other key systems in assigned studies</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.</p><p style="margin: 0cm; margin-bottom: .0001pt;">• As a customer-facing role, this position will build business relationships and represent company with investigators</p><p style="margin: 0cm; margin-bottom: .0001pt;">• Shares protocol-specific information and best practices across countries\clusters</p><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><p style="margin: 0px;">Required:<br />• University/college degree (life science preferred) or certification in a related allied health<br />profession (i.e. nursing, medical or laboratory technology) from an appropriately<br />accredited institution<br />Preferred:<br />• Master or other advanced degree<br />• PMP certification</p><h2>Experience:</h2><p style="margin: 0px;">Minimum Required:<br /> Minimum of five (5) years of relevant clinical research experience in a pharmaceutical<br />company/CRO.<br /> In lieu of the above requirement, candidates with (a) six (6) years supervisory experience<br />in a heath care setting and (b) five (5) years clinical research experience including one (1)<br />years of project management experience (international clinical trial management<br />experience preferred) in the pharmaceutical or CRO industries will be considered<br /> Preferred:<br />Regional project management experience<br />On the Job Experience:<br /> Working knowledge of ICH Guidelines and GCP including international regulatory<br />requirements for the conduct of clinical development programs.<br /> Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)<br /> Experience managing projects in a matrix and virtual environment<br /> Excellent communication, planning and organizational skills<br /> Demonstrated ability to lead by example and to encourage team members to seek solutions<br />independently<br /> Demonstrated ability to handle multiple competing priorities and to utilize resources<br />effectively</p><p style="margin: 0px;">Demonstrated ability to inspire effective teamwork and motivate staff within a matrix<br />system<br /> Financial awareness and ability to actively utilize financial tracking systems<br /> Working knowledge of project management processes<br /> Ability to work independently and mentor junior project team members<br /> Ability to negotiate and liaise with clients in a professional manner<br /> Ability to present to staff at all levels</p>

Job posted: 2022-01-06

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