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 100countries, Fortrea is transforming drug and device development forpartners and patients across the globe. Senior Clinical DataManager - fully home-based Joining Fortrea’s Clinical DataManagement sponsor dedicated team will offer a rewarding career, achance to work in an energetic & team-oriented workplace andexposure within a world-leading team. With the support ofexceptional people from across the globe and a vast array of careeroptions, you’ll be empowered to own your career journey withmentoring, training and personalized development planning. TheSenior Clinical Data Manager role is a great opportunity to workwithin our sponsor dedicated department and have this uniquerelationship with a sponsor. You will be responsible for the fullcycle of Clinical Data Management queries, from being in fullleadership of your own studies and being the main point of contactwith the client, to the most hands-on tasks such as creating eCRFs,cleaning data and performing independently set-up to close-outsduties. You will cooperate in a highly collaborative environmentwith other Clinical Data Managers, Data Coordinators, StatisticalProgrammers and others. What you can expect from us Office based orhome based anywhere in the listed countries Rewarding andmeaningful work in an established, diverse, highly profitable andrespected global company Highly competitive compensation packages,including various local benefits such as pension contributions,complimentary health insurance plans, remote working allowancesetc. A genuine work life balance Flexibility in working hours Athorough onboarding with support from your personal mentor Apermanent employment contract with Fortrea Drug Development and arewarding career progression Your responsibilities Provides CDMleadership for one or more assigned projects or indicationsdependent on size and scale of the project. Takes globalaccountability and serves as the second line of contact at theproject level Lead studies including (but not limited to) acombination of healthy volunteer and patient populations,multi-site, complex protocol design, strong client managementrequired or reduced timelines. Ability to organize and effectivelyprioritize workload and deliverables Demonstrates leadership andoperational expertise in the strategic planning and delivery of CDMdeliverables at program and/or project level. Management andoversight of vendor contracts, resourcing and budget management andoversight of vendor performance for assigned programs, and projectsCommunicates and negotiates effectively with all other Programlevel team members. Primary point of contact for Clinical DataManagement (CDM) Demonstrates a business understanding of thecompound profile to identify and assist in successful applicationof consistent CDM processes and documentation across assignedprograms, (i.e. ensuring consistency across data quality plans.)Provide oversight and expertise of external service providers orin-house teams to deliver quality data with compliance to studymodel procedures and standards; give guidance on company standards,processes, systems and expectations to external partners, internalpartners and third-party vendors Responsible for proactive riskmanagement and issue resolution/escalation connected to ClinicalData Management improvement or technology Develops an understandingof CDASH and SDTM or other recognized industry standards and impactto programming team to ensure consistency of program levelstandards. Specialist in TA specific data capture and standards,conducts lessons learned and disseminate across the organization asappropriate May act as a team leaders or mentor Clinical DataManagement colleagues and any stakeholder with operationalprocesses used in studies and projects. Demonstrates willingness totake on and lead any project level activity consistent with currentor experience in support of study delivery Your profileUniversity/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). 8 yearsof combined early or late-stage DM experience with minimum 2 yearsof direct sponsor management and at least 2 years technicalmentoring experience. Proven experience in handling customernegotiations and experience with managing Scope of Work andbudgets. Extensive experience in clinical data management andexperience leading studies in a CRO/Pharma setting. Excellent oraland 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 teamsby example on project strategies and achievement of departmentgoals, objectives, and initiatives and to encourage team members toseek solutions. Demonstrated managerial and interpersonal skills.LI-MA1 LI-Remote LI-Hybrid 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 you require a reasonableaccommodation to complete your job application, pre-employmenttesting, job interview or to otherwise participate in the hiringprocess, please contact: taaccommodationsrequestfortrea.com .Please note that this e-mail address is only for job seekersrequesting an accommodation. Please do not use this e-mail to checkthe status of your application.
