Bucharest, Bucharest, Romania
In depth knowledge and skilled in applying, clinical regulatory requirements, GCP and ICH guidelines. Extensive experience in all clinical trials, phase I, II, III and IV in gastroenterology, cardiology, hematology, oncology, infectious diseases, pulmonology, rheumatology, rare disease and general surgery.
- Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements, GCP and ICH guidelines. - Work with sites to adapt, drive and track subjects recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communications with sites manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. - Manage the process af assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission and data query generation and resolution. - Act as mentor for clinical staff including conducting co-monitoring and training visits. - Collaborate and liaise with study team members for project execution support as appropriate.
- Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements, GCP and ICH guidelines. - Work with sites to adapt, drive and track subjects recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communications with sites manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. - Manage the process af assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission and data query generation and resolution. - Act as mentor for clinical staff including conducting co-monitoring and training visits. - Collaborate and liaise with study team members for project execution support as appropriate.
- Ensure compliance of the trial conduct with the protocol and the applicable guidelines and regulations. - Review patient documents, compliance with the protocol. - Ensure that AEs, PDs and other safety-related items are correctly reported. - Participate in site pre-study, initiation, routine monitoring, and study closeout visits in-line with SOPs and Protocols. - Training and re-training of new research personnel, physicians, nurses and pharmacists as required during the study. - Monitoring study sites, ensuring site's completion of regulatory activities and integrity of clinical data in adherence to all applicable regulatory guidelines and SOPs.
- Deploying excellent sales drivers (quality, visibility and distribution). - Monitored drug therapy for contraindications, allergies, and appropriateness identify and manage the risks to the patients. - Set standards and policies that all legal and professional requirements are adhered to. - Develop collaborative development strategies to ensure long-term success.
* Creating regional sales plans and quotas in alignment with business objectives. * Supporting Store Managers with day-to-day store operation. * Evaluating store and individual performances. * Hardware accessories sales department
* Creating regional sales plans and quotas in alignment with business objectives. * Supporting Store Managers with day-to-day store operation. * Evaluating store and individual performances. * Hardware accessories sales department
* Creating regional sales plans and quotas in alignment with business objectives. * Supporting Store Managers with day-to-day store operation. * Evaluating store and individual performances. * Hardware accessories sales department