Clinical Project Manager FINLAND, Oncology

<h2>Job Overview:</h2><p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: arial, helvetica, sans-serif;"><span style="color: black; font-size: 9pt;">Labcorp Drug Development</span> is lo</span>oking for a Clinical Project Manager with Oncology experience, based in Finland. This is a 100% Client-dedicated role.</span></p><p style="margin: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">This role involves working directly with a leading global pharmaceutical company in Oncology.  Ideally the successful candidate will be office based in Helsinki, however for the right candidate homebased is also possible.</span></p><p style="margin: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Key Duties include:</span></p><ul><li style="color: #000000;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Manages and is responsible for all activities related to global and/or local clinical trials from the study concept to the clinical study research report.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Leader of the Study Team, from the request of core Study Team members to study close-out contributes to the Study Concept development with regard to its operational aspects, if assigned already.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Develops the comprehensive overview and operational plans for the study by developing and maintaining the Study Plan.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Contributes to risk management activities of GCT and responsible for study specific oversight and risk mitigation activities as described in the Study Plan.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Supports the strategic study feasibility and manages operational study feasibility conducted by country organization to determine study feasibility and final country selection based on the feasibility summary, develops study timelines, milestones, outsourcing plan and proposed external study budget in close collaboration with the study team assists in the development of the core study documents and processes.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Assists in the preparation of the study protocol.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Responsible for developing the total external study budget and accountable for providing monthly and yearly estimates.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Responsible for tracking study budget, initiating payments, forecasting and providing monthly information to controlling and GCL, identifying budget/estimate issues.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Verifying all relevant IT-systems are updated with current and accurate information (e.g. IMPACT).</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Identifies, implements, leads and manages a cross-functional core Study Team for the duration of the study, working with functional line management to identify team members and resolve issues. The Core study team members include: Study Medical Expert, Study Statistician, Study Data Manager and the Study Lead Monitor disseminates relevant information to team members in effective and timely manner.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Represents the study team as a member of the Global Clinical Team.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Manages, tracks, and is responsible for verifying ongoing study activities, study execution and timelines are met.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Tracks and compiles patient enrolment, data cleaning progress and overall study progress.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Assesses and analyses study information for variances and takes necessary actions within his/her responsibility to resolve variances, if necessary.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Initiates action with functional heads to resolve variances.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Develops appropriate study related training for study team representatives (in particular for Monitors) and site personnel according to GCP and BHP global development standards to confirm quality and requirements necessary for global regulatory approvals and marketing needs are met.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Act as Responsible Outsourcing Person in outsourced studies and manages the selection and oversight of other external suppliers (e.g. Central Labs, central ECG reading center, etc.).</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Selects and develops contract specifications for external supplier in collaboration with global strategic sourcing manager.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Responsible for defining outsourced tasks, developing outsourcing plan, training and managing external suppliers to confirm compliance with timelines and budget.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Identifies milestone achievements to initiate payments to external suppliers.</span></li><li style="color: #000000; font-family: 'Arial',sans-serif; font-size: 9pt;"><span style="font-size: 9pt;">Advises and manages Study Committees and external expertise.</span></li></ul><p style="margin: 0px;"><span style="font-size: 9pt;"><span style="color: black; font-family: 'Verdana','sans-serif'; font-size: 9pt;">REMOTE</span></span></p><h2>Education/Qualifications:</h2><p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Bachelor’s degree or equivalent education with 7 – 8 years of relevant healthcare experience and 3 years clinical operations experience in the Pharmaceutical Industry, </span></p><p style="margin: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"> </p><h2>Experience:</h2><p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Strong Clinical Trial/Study Management experience</span><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">, working in the field of Oncology. </span></p><p style="margin: 0cm 0cm 0pt;"> </p><p style="margin: 0cm 0cm 0pt;"><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Experience managing  Phase II – IV global clinical trials, and  an in-depth knowledge of Good Clinical Practice (GCP), </span><span style="font-family: 'Arial',sans-serif; font-size: 9pt;">Federal Regulations and International Regulations (International Harmonization Committee-ICH Regulations).</span></p>