Study Manager - Bioanalysis

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Labcorp Drug Development</strong> is a global, world-leading Life Science Contract Research Organisation that provides dedicated and fully comprehensive laboratory testing and drug development services to the pharmaceutical industry.</span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"> </span></p><p style="margin-right: 1.8pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">At Labcorp Drug Development, we offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. We put our trust in science and in one another. This is your chance to become part of a team that helps to bring the miracles of medicine to market sooner, as Labcorp has helped pharmaceutical and biotech companies develop one-third of all prescriptions medicines in the market today.</span></p><p style="margin-right: 1.8pt;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Our site in Harrogate, North Yorkshire is currently recruiting for a Lead Scientist/Study Director to join the Immunochemistry team within the Bioanalysis division. The Bioanalysis division is responsible for providing analytical testing services to key pharmaceutical and biotech clients to support toxicology and clinical studies. </span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"> </span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">As the <strong>Lead Scientist, you will act as the </strong><span style="color: #333333;"><strong>Study Director, Responsible Scientist, or Principle Investigator</strong> for non-regulated, GLP-regulated, and GCP-regulated bioanalysis studies. You will also:</span></span></p><ul><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: #333333;">Serve as the primary point of contact for scientific & regulatory requirements, with responsibility for </span><span style="color: black;">leading and directing scientific work to support client programs</span></span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: #333333;">Develop and review study protocols and sample analysis plans to </span><span style="color: black;">achieve defined milestones along the drug development pathway</span></span></li><li><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">Review data alongside the method development team to ensure methods are ready for validation and approve validation & sample analysis methods</span></li><li><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">Review and approve reports for scientific accuracy and completeness</span></li><li><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">Actively collaborate with the bioanalysis team to ensure the clients’ studies are completed to the highest possible standard</span></li><li><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">Promote a positive impression of Labcorp Drug Development internally and within the industry.</span></li><li><span style="font-family: arial, helvetica, sans-serif; color: black; font-size: 12pt;">Proactively identify ways to increase client satisfaction</span></li></ul><p style="margin: 0px;"><strong><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">The Lead Scientist position is an office-based role, with no hands on lab work</span></strong></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>What Labcorp Drug Development can offer you:</strong></span></p><ul><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Competitive salaries and a comprehensive benefits package including health cover and contributory </span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Unrivalled opportunities to develop a successful career in the scientific industry</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Unsurpassed career development opportunities. With the support of exceptional people from across the globe and an energized purpose, you will be empowered to own your career journey with mentoring, training and personalized development planning</span></li><li style="margin-left: 18.0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to work with a variety of different people and clients on wide ranging projects</span></li></ul><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">Relocation assistance may be available for this role and remote working can be considered</span></strong></span></p><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12.0pt; font-family: 'Calibri',sans-serif; color: #1a1a1a;">Scientific Degree - BSc, MSc/PhD or equivalent</span></li></ul><h2>Experience:</h2><ul><li><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">Must have experience managing regulated studies in the role of a Study Director or equivalent</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: #333333;">GLP/GCP study management</span></span></li><li><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">Knowledge of global regulatory medicine agencie’s guidelines</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: #333333;">Experience of ELISA, MSD^® and Gyrolab^® technologies preferred</span></span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: #333333;">Experience of Watson^® LIMS preferred</span></span></li><li><span style="font-family: arial, helvetica, sans-serif; color: #333333; font-size: 12pt;">Excellent communication and interpersonal skills</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: #333333;">Proven ability to prioritize and manage time</span><span style="color: #333333;">, with e</span><span style="color: #333333;">xcellent attention to detail</span></span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="color: #333333;">A</span><span style="color: #333333;">bility to utilize word processing, database, spreadsheet, and specialized software</span></span></li></ul>