Senior Clinical Data Manager - single sponsor [ApplyNow]

Fortrea
Maidenhead
1 month ago
Applications closed

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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 - 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 basedor home based anywhere in the listed countries - 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 DrugDevelopment and a rewarding career progression Yourresponsibilities - Provides CDM leadership for one or more assignedprojects or indications dependent on size and scale of the project.Takes global accountability and serves as the second line ofcontact at the project level - Lead studies including (but notlimited to) a combination of healthy volunteer and patientpopulations, multi-site, complex protocol design, strong clientmanagement required or reduced timelines. Ability to organize andeffectively prioritize workload and deliverables - Demonstratesleadership and operational expertise in the strategic planning anddelivery of CDM deliverables at program and/or project level.Management and oversight of vendor contracts, resourcing and budgetmanagement and oversight of vendor performance for assignedprograms, and projects - Communicates and negotiates effectivelywith all other Program level team members. Primary point of contactfor Clinical Data Management (CDM) - Demonstrates a businessunderstanding of the compound profile to identify and assist insuccessful application of consistent CDM processes anddocumentation across assigned programs, (i.e. ensuring consistencyacross data quality plans.) - Provide oversight and expertise ofexternal service providers or in-house teams to deliver qualitydata with compliance to study model procedures and standards; giveguidance on company standards, processes, systems and expectationsto external partners, internal partners and third-party vendors -Responsible for proactive risk management and issueresolution/escalation connected to Clinical Data Managementimprovement or technology - Develops an understanding of CDASH andSDTM or other recognized industry standards and impact toprogramming team to ensure consistency of program level standards.- Specialist in TA specific data capture and standards, conductslessons 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 willingnessto take on and lead any project level activity consistent withcurrent or experience in support of study delivery 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). - 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. - 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 leadteams by example on project strategies and achievement ofdepartment goals, objectives, and initiatives and to encourage teammembers to seek solutions. - Demonstrated managerial andinterpersonal skills. #LI-MA1 #LI-Remote #LI-Hybrid Fortrea isactively seeking motivated problem-solvers and creative thinkerswho share our passion for overcoming barriers in clinical trials.Our unwavering commitment is to revolutionize the developmentprocess, ensuring the swift delivery of life-changing ideas andtherapies to patients in need. Join our exceptional team andembrace a collaborative workspace where personal growth isnurtured, enabling you to make a meaningful global impact. For moreinformation about Fortrea, visitwww.fortrea.com. Fortrea is proudto be an Equal Opportunity Employer: As an EOE/AA employer, Fortreastrives for diversity and inclusion in the workforce and does nottolerate harassment or discrimination of any kind. We makeemployment decisions based on the needs of our business and thequalifications of the individual and do not discriminate based uponrace, religion, color, national origin, gender (including pregnancyor other medical conditions/needs), family or parental status,marital, civil union or domestic partnership status, sexualorientation, gender identity, gender expression, personalappearance, age, veteran status, disability, genetic information,or any other legally protected characteristic. We encourage all toapply. For more information about how we collect and store yourpersonal data, please see our Privacy Statement. If you require areasonable accommodation to complete your job application,pre-employment testing, job interview or to otherwise participatein 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.

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