FSP Senior CRA - fully client dedicated - Norway

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.This is a great opportunity for experienced CRA's currently working within the life science sector for pharmaceutical companies, biotech companies or CRO's to work with a world-leading CRO.Essential FunctionsMonitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.Assess investigational product through physical inventory and records review.Documents observations in reports and letters according to timelines using approved business writing standards.Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.Contributes to other project work and initiatives for process improvement, as required.Education And ExperienceUniversity degree in a science related fieldUnderstanding of ICH-GCP, EU and FDA requirementsFluency in EnglishValid driver's licenseKnowledge, Skills And AbilitiesProven clinical monitoring skills, minimum experience in the CRA role is 3 years.Demonstrated understanding of medical/therapeutic area knowledge and medical terminology within Cell & Gene TherapyDemonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documentsWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solvingAbility to manage Risk Based Monitoring concepts and processesGood oral and written communication skills, with the ability to communicate effectively with medical personnelAbility to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issuesGood organizational and time management skillsEffective interpersonal skillsAttention to detailAbility to remain flexible and adaptable in a wide range of scenariosAbility to work in a team or independently as requireGood computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate softwareCRA with experience from all study phases from start to close-outAs well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.Our 4i ValuesIntegrity – Innovation – Intensity – InvolvementIf you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!Clinical Research | Thermo Fisher ScientificOur team of colleagues in clinical research services are at the forefront of getting cures to market.