As a leading global contract research organization(CRO) with a passion for scientific rigor and decades of clinicaldevelopment experience, Fortrea provides pharmaceutical,biotechnology, and medical device customers a wide range ofclinical development, patient access, and technology solutionsacross more than 20 therapeutic areas. Conducting operations in~100 countries, Fortrea is transforming drug and device developmentfor partners and patients across the globe. Senior Clinical DataManager (remote or hybrid) - Late Phase Do you have experienceleading data management activities across late phase studies? Areyou looking for a new challenge in an environment where you beclosely supported by your Manager, peers and Senior Leaders in yourteam? Join our growing team and discover your extraordinarypotential by working as a Senior Clinical Data Manager within ourLate Phase team. What you can expect from us - Office based or homebased anywhere in Europe or South Africa. - Rewarding andmeaningful work in an established, diverse, highly profitable andrespected global company - Highly competitive compensationpackages, including various local benefits such as pensioncontributions, complimentary health insurance plans, remote workingallowances etc. - A genuine work life balance - Flexibility inworking hours - A thorough onboarding with support from yourpersonal mentor - A permanent employment contract with Fortrea Inthis opportunity, you wil - Serve as the technical leader on alldata management aspects for project(s) including start-up,maintenance, and completion activities. - Develop global DataManagement Plans and Quality Management (QM) Plans that willdeliver accurate, timely, consistent, and quality clinical data. -Identify and implement solutions to project data management issuesand concerns, including proactive prevention strategies based onmetrics and forecasts. - Serve as the project and client liaisonincluding management and provision of project specific datamanagement status, cycle time, and productivity metrics. -Coordinate and participate in the development of the clinical datamodel and/or database design and annotate the CRF (eCRF) accordingto these specifications. - Review data acquisition conventions anddata review guidelines / diagnostic specifications consistent withthe clinical data model, [statistical] analysis plans, and CRF(eCRF) completion / monitoring conventions. - Coordinate thedevelopment and testing of data management systems edit / datavalidation checks) diagnostics) and special listings / proceduresused as tools for the data review and discrepancy managementactivities. - Interact and collaborate with other project andspecialty team members (clinical, programming, statistics, CDMtechnical support, drug safety, etc.) to support the set-up,maintenance, and closure of the data management aspects of theproject to ensure consistent, cohesive data handling and quality. -Advanced planning and risk management for projects (issueescalation, resource management). - Oversee the technicalperformance of the data review project staff on achieving clientsatisfaction through delivery of quality data, on-time andon-budget. - Assist with goal creation and performance reviewassessment for data review project staff. - Maintain technical datamanagement competencies via participation in internal and externaltraining seminars. - Ensure project staff are trained and adhere toproject-specific, global, standardized data management processes. -Identify areas for process and efficiency improvement and implementsolutions on assigned projects. - Support achievement of projectrevenue and operating margin for data management activities toagreed targets. - Support business development for data managementtime and cost estimates and prepare and present to potentialclients on global data management capabilities. Your profile -University/college degree (life science, pharmacy or relatedsubject preferred), or certification in a related allied healthprofession from an appropriately accredited institution (e.g.,nursing certification, medical or laboratory technology). -Additional relevant work experience will be considered in lieu offormal qualifications. - Lead experience across a mix oftherapeutic areas especially across Late Phase (IIb-III) trials. -EDC experience - ideally you will have RAVE experience andexperience across other EDCs would be advantageous. - Excellentoral and written communication and presentation skills. - In depthknowledge of clinical trial process and data management, clinicaloperations, biometrics, quality management, and systemsapplications to support operations. - Working knowledge of therelationship and regulatory obligation of the CRO industry withpharmaceutical / biotechnological companies. - Ability to lead byexample teams on project strategies and achievement of departmentgoals, objectives, and initiatives and to encourage team members toseek solutions. Fortrea is actively seeking motivatedproblem-solvers and creative thinkers who share our passion forovercoming barriers in clinical trials. Our unwavering commitmentis to revolutionize the development process, ensuring the swiftdelivery of life-changing ideas and therapies to patients in need.Join our exceptional team and embrace a collaborative workspacewhere personal growth is nurtured, enabling you to make ameaningful global impact. For more information about Fortrea, visitwww.fortrea.com. Fortrea is proud to be an Equal OpportunityEmployer: As an EOE/AA employer, Fortrea strives for diversity andinclusion in the workforce and does not tolerate harassment ordiscrimination of any kind. We make employment decisions based onthe needs of our business and the qualifications of the individualand do not discriminate based upon race, religion, color, nationalorigin, gender (including pregnancy or other medicalconditions/needs), family or parental status, marital, civil unionor domestic partnership status, sexual orientation, genderidentity, gender expression, personal appearance, age, veteranstatus, disability, genetic information, or any other legallyprotected characteristic. We encourage all to apply. For moreinformation about how we collect and store your personal data,please see our Privacy Statement. If, as a result of a disability,you require a reasonable accommodation to complete your jobapplication, pre-employment testing, job interview or to otherwiseparticipate in the hiring process, please contact:. Please note that this e-mailaddress is only for job seekers requesting an accommodation. Pleasedo not use this e-mail to check the status of yourapplication.
