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Start-up Assoc Project Manager

Laboratory Corporation of America Holdings (Covance)

Sydney, Australia

<h2>Job Overview:</h2><h1><span style="font-size: 12pt;">Are you ready to discover you next career at Labcorp?</span></h1><p style="margin: 0px;"><span>We are seeking an exceptional person with study startup experience that is focussed on advancing their career in Clinical Research to the next level.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span>Our Clinical Research Study Start up Associate Project Managers provide our clinical operations team with support to start up clinical Phase I - IV clinical projects in APAC. Based at our client site in Sydney you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span>Join us as a Start up Associate Project Manager you will be:</span></p><p style="margin: 0px;"> </p><ul style="margin-top: 0cm;"><li><span>Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.</span></li><li><span>Develop local language materials including local language Informed Consents and translations.</span></li><li><span>Collaborate with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.</span></li><li><span>Oversee country and site budgets.</span></li><li><span>Partner with local clinical team/s to successfully deliver clinical and financial contracts within fair market value. -</span></li><li><span>Manage and track clinical research-related payments - Payment reconciliation at study close-out.</span></li><li><span>Ensure country deliverables, timelines and results for assigned protocols are met to meet country commitments.</span></li><li><span>Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.</span></li><li><span>Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.</span></li><li><span>Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials</span></li></ul><p style="margin: 0px;"><span>Labcorp Australia is committed to providing employees the freedom to grow careers across all phases and areas of clinical trial operations as well as provide regular support to develop your experience even when you are based at a client site.</span></p><h2><strong><span>About Labcorp:</span></strong></h2><p style="margin: 0px;"><span>Labcorp Drug Development is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span>You will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Labcorp Drug Development, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span>Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.</span></p><p style="margin: 0px;"><span>We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</span></p><h2>Education/Qualifications:</h2><ul><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting  will be considered</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Thorough understanding of the drug development process</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Fluent in local office language and in English, both written and verbal</span></li></ul><h2>Experience:</h2><ul><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Good organizational and time management skills</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Excellent communication skills, oral and written.</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Self-motivation with the ability to work under pressure to meet deadlines</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Works well independently as well as in team environment.</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Detail and process oriented</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Positive attitude and approach</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Interact with internal and external customers with high degree of professionalism and discretion</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;"><span style="font-size: 10.0pt;">Multi-tasking capability.</span></li><li style="margin: 0cm 0cm .0001pt 18.0pt;">Ability to lead and develop junior staff</li><li style="margin: 0cm 0cm .0001pt 18.0pt;">Flexible and adaptable to a developing work environment</li><li style="margin: 0cm 0cm .0001pt 18.0pt;">Minimum of four-six (4-6) years of clinical research experience</li></ul>

Job posted: 2021-09-03

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