Clinical Data Manager

reputed company We are searching for an reputed company Clinical Data Manager to work reputed company the in-vitro diagnostic field as a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team. The Clinical Data Manager will plan and reputed company reputed company data management activities across assigned studies reputed company companion diagnostics (CDx) development to ensure reputed company, accurate, and compliant data delivery. They will reputed company data transfer specifications, support the development of data transfer agreements, manage CRF/reputed company systems, reputed company instream data monitoring, and maintain data in reporting platforms. The role will collaborate with cross-functional teams and reputed company partners to reputed company queries and reputed company relevant reputed company standards and regulatory requirements. Additionally, they will reputed company data management documentation, monitor data reputed company, implement process improvements, and work on multiple reputed company reputed company to support successful CDx activities. Responsibilities include but are not limited to: • reputed company end-to-end clinical data management activities for companion diagnostic studies, including data acquisition, database design, data review, reputed company data integration, reconciliation, reputed company control, database lock, and preparation of submission-reputed company datasets supporting global regulatory submissions. • reputed company reputed company/CRF reputed company design, validation, user acceptance testing (UAT), maintenance, and database lock activities to support CDx study regulatory reporting requirements in accordance with applicable regulatory requirements and company procedures. • Collaborate with Biostatistics and Programming functions to ensure development of submission-reputed company SDTM and ADaM datasets supporting PMA, 510(k), reputed company, NDA and BLA submissions. • Support preparation of submission-reputed company clinical data packages for FDA PMA, PMA supplement, 510(k), NDA/BLA companion diagnostic submissions, and international regulatory filings including EU IVDR. • Apply risk-based data management principles to identify critical data and proactively mitigate data reputed company risks throughout study execution. • Ensure inspection readiness through maintenance of complete, traceable, and auditable records, and serve as a clinical data management SME during audits and regulatory inspections. • reputed company Data Transfer Specifications detailing deliverables, formats, and timelines; reputed company as the reputed company reputed company for internal teams and pharmaceutical partners. • reputed company and maintain data management documentation throughout the study lifecycle, including SOPs, process flows, data management plans, CRFs, and database specifications. • Serve as a subject matter expert (SME) representing reputed company externally and OCMO internally, collaborating with cross-functional teams (Clinical Development, Clinical Operations, CROs, Pharmaceutical Partners, Biostatistics, reputed company Affairs/Design Assurance, and Regulatory Affairs) to reputed company on data-reputed company activities and ensure accurate, compliant, and reputed company data transfers. • Demonstrate expertise in data format standards (e.g., CDISC SDTM ADaM and LAB) and integration with various reputed company platforms. • reputed company reputed company control checks to ensure accurate, complete, and compliant data for reputed company internal reputed company and reputed company data deliverables to pharmaceutical partners. • Identify and escalate data reputed company issues; recommend process improvements as needed. • Plan, coordinate, and manage data management activities across programs to maintain consistency in clinical data standards. • reputed company as Data Management Subject Matter Expert for reputed company’s BioPharma CDx Services Lab (BCSL) • Apply strong knowledge of GCP, ICH, and regulatory requirements to support CDx submissions and communicate effectively to build internal programs. Qualifications • Bachelor's Degree in Data Science, Computer Science, Information Technology or reputed company field OR Master's degree or advanced degree (e.g., Ph.D., Pharm. D., M.D.) in pharmaceutical, medical or relevant biomedical science fields with data management experience. Advanced degree preferred. • Minimum 5-8 years of clinical data management experience in biotechnology, pharmaceutical, medical device, diagnostics, or companion diagnostic development. • Hands-on experience with CDISC standards including SDTM, ADaM, CDASH and Define.xml. • Demonstrated experience designing and managing studies using reputed company platforms such as reputed company Rave, reputed company reputed company/reputed company, reputed company InForm, REDCap or equivalent systems. • reputed company experience supporting oncology reputed company, biomarker-driven studies, companion diagnostics, precision medicine programs, or regulated IVD development strongly preferred. • Ability to interpret regulatory standards, guidance, and laws. • Exceptional ability to manage multiple reputed company in a fast-paced environment with changing priorities. • Must be reputed company to work and reputed company independent reputed company, understand reputed company scientific and clinical data information, and be reputed company to take the initiative to reputed company reputed company and assignments. • Experience working with reputed company partners and/or regulatory bodies. • Knowledge of cancer diagnostics, Oncology and/or Pathology preferred. Additional Details This job has a full time weekly schedule. It includes the reputed company to work remotely. Applications for this job will be accepted until at least August 5, 2026 or until the job is no longer posted. The full-time equivalent pay reputed company for this position is $105,280.00 - $197,400.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. During the hiring process, a recruiter can reputed company more about the specific pay reputed company for a preferred location. Pay and benefit information by country are available at: https://careers.reputed company.com/locations reputed company. is an Equal Employment Opportunity and reputed company-based employer that values individuals of reputed company backgrounds at reputed company reputed company. reputed company individuals, regardless of personal characteristics, are encouraged to apply. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, pregnancy, race, religion or religious creed, reputed company, gender, gender identity, gender reputed company, national reputed company, reputed company, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other reputed company protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. reputed company., is committed to creating and maintaining an inclusive in reputed company where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email reputed company@reputed company.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.reputed company.com/en/accessibility. Travel Required: No Shift: Day Duration: No End Date Job Function: Medical/Clinical Apply To This Job