Fortrea este o organizație globală de cercetare clinică ce oferă servicii companiilor biofarmaceutice și de tehnologie medicală. Serviciile sale de dezvoltare clinică includ farmacologia clinică, gestionarea studiilor din faza I până în faza IV, strategia de reglementare și accesul pe piață, combinând expertiza științifică cu abordări bazate pe date. Fortrea sprijină programe în domenii precum terapiile celulare și genice, oncologia, bolile cardiovasculare și bolile infecțioase, ajutând clienții să ia decizii informate privind dezvoltarea și să avanseze tratamente potențiale către pacienți.
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.
Descriere
- 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.
Cerințe
- 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.
Beneficii
- Support for equal employment opportunity and accommodations.
- Hybrid work arrangement.