Fortrea je globalna organizacija za klinične raziskave, ki nudi storitve biofarmacevtskim podjetjem in podjetjem s področja medicinske tehnologije. Njene storitve kliničnega razvoja vključujejo klinično farmakologijo, vodenje študij faze I–IV, regulativno strategijo in dostop do trga ter združujejo znanstveno strokovno znanje s pristopi, ki temeljijo na podatkih. Fortrea podpira programe na področjih, kot so celična in genska terapija, onkologija, bolezni srca in ožilja ter nalezljive bolezni, pri čemer strankam pomaga sprejemati informirane odločitve o razvoju in približati morebitna zdravljenja bolnikom.
Senior Clinical Data Manager – Fortrea, Beijing
Lead clinical data management across global pharmaceutical studies, overseeing vendors, data quality, and risk indicators. Partner with cross-functional teams to review study data and support reliable analysis.
Opis
- Manage multiple studies with limited functional oversight.
- Represent Data Management in technical discussions at study team meetings.
- Share Data Management processes with study colleagues and cross-functional peers.
- Oversee multiple Data Management vendors and train junior colleagues, providing subject matter expertise.
- Contribute Data Management expertise to drug development programs.
- Provide functional expertise in areas such as data standards, medical coding, eSource, external data, visualization, and analytics.
- Review Key Risk Indicator outputs across sites, regions, and countries.
- Analyze study operational and patient data to investigate observations and identify root causes.
- Assess centralized monitoring findings to identify potential study issues and risks.
- Oversee vendors across studies and improve oversight processes.
- Track vendor performance using metrics and key performance indicators.
- Record process deviations and report them to the functional manager.
- Raise concerns or act promptly when Data Management deliverables may not meet quality expectations.
- Use cross-functional knowledge to assess how Data Management processes affect stakeholders.
- Lead data review meetings with Medical, Clinical Operations, Biostatistics, and Programming teams.
- Discuss protocol deviations and data values relevant to analysis and subject population decisions.
- Apply regulatory requirements, including GCP, to Data Management work and deliverables.
Zahteve
- Bachelor’s degree in biological science, a health-related field, or computer science, or equivalent experience.
- Typically eight or more years of relevant experience in pharmaceuticals, clinical research, or health services.
- At least six years as a Data Manager with increasing leadership responsibility.
- Expertise spanning Data Management program initiation through regulatory submission; submission experience is preferred.
- Recognized leadership and subject matter expertise in global Data Management process improvement initiatives.
- Extensive experience managing external data and digital health solutions, including eSource, eCOA, eConsent, electronic data processes, central monitoring tools, and RBQM principles.
- Advanced knowledge of clinical data standards such as CDISC and the ability to apply them across studies and programs.
- Strong computer skills, including database management, reporting tools, and medical coding systems.
- In-depth knowledge of clinical trial data sources and related data quality considerations.
- Previous inspection and audit experience.
- Proven project management and organizational skills to prioritize and direct work for self and others while meeting timelines.
- Ability to guide and influence study teams, drive decisions, and resolve issues across functions and vendors.
- Critical thinking and sound judgment in complex or ambiguous Data Management situations.
- Adaptability in learning and ability to encourage adoption of new Data Management technologies and capabilities.
- SCDM Certified Clinical Data Manager credential preferred.
- Experience with RAVE, eClinical Solutions elluminate, and CluePoints is a plus.
Ugodnosti
- Support for equal employment opportunity and accommodations.
- Hybrid work arrangement.