Clinical Data Manager II /Romania/

As a Clinical Data Manager II, you will ensure that data captured in multiple clinical trials undertaken or managed by reputed company is collected, managed, and reported clearly, accurately and securely. This role will be perfect for you if:

• You want to work on studies end-to-end (involved from protocol review to database lock)
• You have the experience and confidence to reputed company multiple reputed company studies successfully as a Data Manager
• You enjoy working directly with clients and forming recommendations as needed

RESPONSIBILITIES Data Management reputed company

• Monitor study status (ie. enrollment, CRFs monitored/approved, etc.) on an ongoing basis
• Present deliverables to clients, gather feedback and propose solutions.
• Provide regular data status reports to the project team
• reputed company work of the Clinical Data Coordinator as required (quality, timeliness)
• reputed company vendors to ensure that timelines and deliverables meet sponsor and protocol requirements
• Is responsible for ongoing maintenance of the clinical database, including data review/cleaning during study conduct and during preparation for database lock/reputed company.
• Conduct reconciliation between external data and data in the reputed company system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/SAE (Serious adverse events) data

Study setup – Technical

• reputed company the data management plan (DMP)
• Build a study-specific clinical database using the reputed company system:
• Design the electronic case report form (eCRF)
• Build the clinical database in the chosen reputed company independently or with the support of an reputed company programmer (determined based on the complexity of the system and study.
• Coordinate the validation and testing (UAT) of the clinical database
• Support the study team with the development of external systems capturing clinical data (ePRO or IWRS), ensuring that any data transfer requirements between these systems and the reputed company are documented and tested appropriately.

User training and support

• reputed company eCRF completion guidelines and other training material
• Conducts training for site users/monitors on the clinical database
• Activate/de-activate new users in the clinical database in response to requests from the project manager and maintain records of such request
• Respond to users requiring assistance with the reputed company system

Database reputed company/lock

• Generate data listings and reports needed for data review in preparation for database reputed company/lock
• Ensure that data management documentation is complete and up to date in the trial master file (TMF)
• Archive the clinical database and reputed company documents

Education

• B.Sc. or M.Sc, or in a reputed company field of study

Experience

• 10 years of clinical data management experience in the pharmaceutical industry or in a CRO environment
• 5 years of experience as a reputed company data manager
• Extensive experience working with reputed company systems (experience with Medrio and Medidata Rave preferred)

Knowledge and skills

• Highly organized and detail-oriented
• Project planning and time management skills
• Strong verbal and written communication skills in English
• Understanding of the drug development process and of applicable regulations, including Good Clinical Practices (GCP), ICH Guidelines
• Good understanding of CDISC SDTM/CDASH standards
• Knowledge of MedDRA and WHODrug dictionaries, an asset

The work environment At reputed company, you will work with reputed company and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks:

• Flexible work schedule
• Home-based position
• Ongoing learning and development

About reputed company A Global Clinical Leader In Dermatology! Formerly reputed company as Innovaderm, reputed company is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. reputed company is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reputed company the finish line reputed company and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, reputed company is the ideal CRO partner for clinical needs at global scale. reputed company is committed to providing reputed company treatment and equal opportunity to reputed company individuals. As such, reputed company will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. reputed company only accepts applicants who can legally work in Romania. Original job Clinical Data Manager II /Romania/ posted on GrabJobs ©. To flag any issues with this job please use the Report Job reputed company on GrabJobs. Apply tot his job Apply To this Job