Project Manager, Laboratory

Project Manager - Office based Home based Bangalore Chennai Trivandrum ICON plc is a world-leading healthcare intelligence and clinical research organization We re proud to foster an inclusive environment driving innovation and excellence and we welcome you to join us on our mission to shape the future of clinical development ICON plc is a world-leading healthcare intelligence and clinical research organisation From molecule to medicine we advance clinical research providing outsourced services to pharmaceutical biotechnology medical device and government and public health organisations With our patients at the centre of all that we do we help to accelerate the development of drugs and devices that save lives and improve quality of life Our people are our greatest strength are at the core of our culture and the driving force behind our success ICON people have a mission to succeed and a passion that ensures what we do we do well The Role Project Manager - Laboratory IT and Data Integrity Contract 12 months Lead the planning and implementation of data integrity procedures and compliance working with a cross functional group within the organisation Facilitate the definition of project scope goals and deliverables Define project tasks and resource requirements Develop full-scale cross-functional project plans Plan and schedule project timelines Qualification of laboratory equipment and associated software Identify gaps in compliance across the laboratory in equipment and software qualification Develop and Manage Risk Mitigation processes when gaps identified Incorporate mitigation processes into standard operating procedures Train laboratory staff on new processes post qualification Track project deliverables using appropriate tools Provide direction and support to project team Communication of project progress to key stakeholders and senior management Quality assurance Constantly monitor and report on progress of the project to all stakeholders Present reports defining project progress problems and solutions Implement and manage project changes and interventions Desirable attributes Laboratory experience clinical pharma production Experience with automated laboratory equipment interfaced to a networked LIMS Strong IT skills and knowledge In depth experience of working with and configuration of a LIMS system Experience in a laboratory or similar environment handling GXP data Knowledge of laboratory equipment and associated software desirable Knowledge of data integrity compliance advantageous Knowledge of lab accreditation processes and standards Experience of working with a quality management system including a robust CAPA process Standard operating procedure creation including document control system desirable LI-JS2 Benefits of Working in ICON Our success depends on the knowledge capabilities and quality of our people That s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development At ICON our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay but also a wide range of variable pay and recognition programs In addition our best in class employee benefits supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now and into the future ICON including subsidiaries is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or protected veteran status If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please let us know through the form below What ICON can offer you Our success depends on the quality of our people That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent In addition to your competitive salary ICON offers a range of additional benefits Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family Our benefits examples include Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead Global Employee Assistance Programme TELUS Health offering 24-hour access to a global network of over 80 000 independent specialised professionals who are there to support you and your family s well-being Life assurance Flexible country-specific optional benefits including childcare vouchers bike purchase schemes discounted gym memberships subsidised travel passes health assessments among others Visit our to read more about the benefits ICON offers At ICON inclusion belonging are fundamental to our culture and values We re dedicated to providing an inclusive and accessible environment for all candidates ICON is committed to providing a workplace free of discrimination and harassment All qualified applicants will receive equal consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or protected veteran status If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please let us know or submit a request Interested in the role but unsure if you meet all of the requirements We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles Are you a current ICON Employee Please click to apply