Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Responsibilities
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site
Assesses site processes and conducts Source Document Review of appropriate site source documents and medical records
Applies query resolution techniques remotely and on site
Responsible for quality deliverables at the country level, ensuring compliance and tracking milestone progress in agreed upon SSU tracking system in real time, and overseeing site activation end to end process at country/ site level.
Responsibilities
Responsible for quality deliverables at the country level
Forecasts submission/approval timelines and tracks milestone progress
Analyzes data to provide clear rationale for delays and provides contingency plans
Monitors financial aspects of the project and available hours/tasks
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI)
Develop and maintain programs to create analysis datasets, tables, and figures, ensuring accuracy and compliance with statistical standards and provide comprehensive statistical programming support for statisticians, clients, or business needs.
Responsibilities
Develop and maintain programs to create analysis datasets, tables, and figures, ensuring accuracy and compliance with statistical standards
Provide comprehensive statistical programming support for statisticians, clients, or business needs, including troubleshooting and resolving programming issues
Source, organize, and interpret complex data sets, utilizing advanced coding techniques to ensure data integrity and usability
Collaborate with statisticians and other stakeholders to understand project requirements and deliver high-quality statistical outputs
Evaluate existing programming processes, identify areas for improvement, and implement revisions to enhance productivity and efficiency
Requirements
Advanced degree in Statistics, Computer Science, or a related field
Nice to have: SAS Certified Advanced Programmer for SAS 9 or equivalent certification
Nice to have: Certification in data analysis or statistical programming
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
Demonstrates diligence in protecting the confidentiality of each subject/patient.
Requirements
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Assists with safety and pharmacovigilance program delivery activities including collection, processing, and reporting of individual cases safety reports (ICSRs)
Literature screening and review for safety
Drug coding and maintenance of drug dictionary
Medical Dictionary for Regulatory Activities (MedDRA) coding
Data management activities including cleaning and validation of data
Experienced SrCRA with oncology experience - Global Sponsor - Homebased in Romania
Responsibilities
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
Assesses site processes and conducts Source Document Review of appropriate site source documents and medical records.
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including Site Selection support, site contracts support, regulatory/ethics submissions, site activities including site activation as well as On-Site Monitoring and/or Central Monitoring through Study Close Out.
Responsibilities
Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling
Review workload for all staff in reporting chain, participate in managing the resource availability for the assigned staff
Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans
Assist in recruiting new staff, including participation in interview process and new hire onboarding
Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP
Contribute talent and expertise in fund accounting and reporting for fund and investment structures within a pan-European platform.
Responsibilities
Maintain accurate and complete accounting records for funds, SPVs and other legal entities, ensuring all financial transactions are properly recorded and reconciled.
Prepare and maintain supporting schedules and perform reconciliations with trial balances.
Oversee accounting prepared by external service providers, ensuring accuracy, completeness, and timeliness.
Record accounting adjustments required for fund, group, and statutory reporting.
Support the preparation of annual financial statements in compliance with local and fund‑specific requirements.
Üstün müşteri hizmeti sunmak, hikaye anlatımı aracılığıyla duygusal bağlar kurmak, sadakat programlarını teşvik etmek ve bireysel/ekip satış hedeflerine ulaşmak.
Responsibilities
Üstün müşteri hizmeti sunmak
Hikaye anlatımı aracılığıyla duygusal bağlar kurmak
Sadakat programlarını teşvik etmek
Bireysel ve ekip satış hedeflerine ulaşmak
Davetkar ve düzenli bir mağaza ortamı yaratmak
Requirements
Nice to have: Moda/lüks/yaşam tarzı markalarına tutku