Clinical Care Manager (Remote)

Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.Job DescriptionReporting to the Clinical Client Care Senior Manager, the Clinical Client Care Manager is responsible for the operational functioning between the clinical studies and the client services team. This may include managing single-center or multicenter clinical study relations and activities with the client services department. This CCCM will possess exceptional customer service skills excelling at building relationships with customers and colleagues to ensure clinical sites and their patients are well supported. The CCCM will work closely with the Director of Program Management, Senior Director of Medical Affairs, and Client Services as applicable, as well as other cross-functional team members/clinical CRO and staff, to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.Clinical Care Manager responsibilities include, but are not limited to, the following:Managing all aspects of the relationship with the clinical sites (client) and client services teamClient services liaisonEnsuring study protocol sample collection windows and expectations are effectively communicated to Client services teamManaging actions and tasks to ensure patients get scheduled and samples get drawn in a timely fashionEnsuring patient sample data is entered into Eurofins labware management system and the Electronic Data Capture system in a timely and accurate mannerMaintaining a neat and accurate record system; keep accurate records of work performed on daily basis or as needed for quality control tests or regulatoryCommunicating problems encountered with specimen handling to the appropriate internal resource as neededIdentifying process difficulties and reporting these together with proposed solutions to the Director of Program ManagementIdentifying non-conformances and out-of-specification issues and investigating to determine the possible root causes with the Client Services teamPerforming periodic audits of CRM records, ensuring accuracy and completeness; developing action plans for addressing any issues identifiedStudy Management (either directly or through a CRO)Ensuring that clinical trials are conducted in accordance with State, Federal or local regulations, Good Clinical Practice regulations, and internal Standard Operating ProceduresManaging meetings, such as Investigator, Coordinator, and/or Monitor Meetings. Activity may include creating an agenda, coordinating meeting logistics, reviewing/creating presentation material, and presenting study-related informationManaging content and timeline for publication of study newsletters and/or other study communicationsDeveloping sample informed consents as well as review and approve site-specific informed consentsAssisting in data management (with CRO as applicable), such as ensuring that clinical study data queries are resolved; resolving patient eligibility and protocol deviation issuesAssisting in preparation of Clinical Study ReportsWriting, reviewing and editing study documents such as Lab Manuals, Study Conduct Manuals, study tools, Recruitment Plans and Monitoring Plans where applicableIdentifying needs for study conduct improvements and ensure relevant improvements are implemented, e.g. defining and implementing a strategy for increasing enrollment, identifying and conducting additional training of site personnel, creation of additional study tools, etc.May generate clinical operations study timelines and assist with generating overall program timelinesMay prepare/write clinical protocols and amendments in conjunction with the Medical Monitor (or designee)Other duties as assigned by Supervisor QualificationsThe Ideal Candidate PossesExcellent attention to detail and commitment to ensuring proper documentationAbility to function independently, and work collaboratively to identify solutionsExcellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organizationAbility to keep sensitive information confidentialHigh level of proficiency with PC based software programsProficient with MS Office (Word, Excel, PowerPoint, Outlook) on Windows operating systemBasic Minimum QualificationsBachelor’s degree in a health-related field (Biology, Nursing, Physiology etc.)Minimum 2 years of clinical operations work experience or related industry experience and a working knowledge of GCP/ICH guidelines and medical device/in vitro diagnostic clinical development process (Lesser duration of clinical operations work may be acceptable depending on the candidate)Management of international clinical studies is a plusMinimum 1 year of experience in a client-facing customer service type rolePrevious experience working with an electronic data capture system preferredA basic understanding of transplant medicine or desire to learn on the jobAuthorization to work in the United States indefinitely without restriction or sponsorshipAdditional InformationThe position is fully remote, full-time, Monday – Friday, 09:00 a.m. to 6:00 p.m., with overtime as needed.Excellent full-time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysPlease be aware that this role will require access to a site that requires COVID-19 vaccination or exemption from vaccination requirements. Prior to starting work in this position, employees must show proof of full Covid-19 vaccination or exemption from vaccination requirements. Exemptions will be granted as warranted by medical contraindications, disability or sincerely held religious beliefs.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.