Oana Avram work email
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Oana Avram personal email
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I lead the Medical Monitoring and Consulting department at PSI CRO, a global contract research organization that specializes in complex and challenging clinical trials. With an MD degree and a specialization in clinical pharmacology, I have over 18 years of experience in clinical research, medical affairs, and medical monitoring across various therapeutic areas and phases.My mission is to ensure the quality and efficiency of medical monitoring services for our clients and partners, as well as to coach and mentor my team of 37 employees. I oversee the administration, strategic planning, and performance evaluation of the department, and initiate process improvement initiatives and best practices. I also collaborate with external and internal customers to understand their requirements and provide exceptional service. I am passionate about advancing the field of clinical research and medical monitoring by applying my expertise and leadership skills.
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Head Medical Monitoring And ConsultingPsi Cro Ag Mar 2023 - PresentZug, Ch• Overall administration of the Medical Monitoring and Consulting department• Strategic planning for the department, including operational objectives and performance goals, budget development • Forecasts and plans for adequate resource utilization within the department, identifies hiring needs, manages, and supervises recruitment of the department staff• Explores and evaluates the function, practices, and procedures of medical monitoring to identify opportunities for improvement• Oversees the process improvement initiatives and implementation of new practices• Evaluates performance, and oversees career advancement of the department staff• Oversees and initiates the development and implementation of training programs within the department• Oversees medical monitoring services bids and budgets and supervises preparation of proposals, proposals and bid defense meetings assignments
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Senior Director Monitoring & ConsultingPsi Cro Ag Jul 2020 - Feb 2023Zug, Ch• Ensured ongoing oversight of Medical Monitors workload and performance within a geographical region (Europe)• Line management of European team (18 employees)• Provided coaching and performance feedback, monitoring team members and team metrics; • Identified the need for corrective actions; ensured quality standards, evaluating the team and employees deliver quality work• Developed and conduct trainings in corporate procedure and practices to medical monitors• Developed and implemented of quality systems documents within the Medical Monitoring & Consulting department• Worked with external and internal customers to understand requirements and provide exceptional service• Negotiated agreements between employees to clarify misunderstood directions and resolve conflicts affecting performance• Provided medical monitoring on a project level when needed
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Director Medical Monitoring & ConsultingPsi Cro Ag Sep 2018 - Jul 2020Zug, Ch• Leading Medical Monitors within the geographical region (Europe – 12 employees)• Contributed to the development and implementation of quality systems documents within the Medical Monitoring & Consulting department• Developed and delivered medical training to medical monitors and other PSI departments• Performed medical monitoring on a project level being the main line of communication for medical matters between the Sponsor and the site and project team• Participated in BID defense meetings
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Medical Affairs ManagerPsi Cro Ag Jan 2011 - Sep 2018Zug, Ch• Provided medical monitoring on a project level being the main line of communication for medical matters between the Sponsor and the site and project team• Participated in the BID defense meetings• Contributed to the establishing relationships with medical community• Developed therapeutic area training programs; supported organization of therapeutic area training and communication with external lecturers• Communicated with customers, sponsors, investigators and key opinion leaders• Audit participation
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Medical MonitorPsi Cro Ag Jan 2009 - Dec 2010Zug, Ch• Provided ongoing consultancy to project teams and clients on medical matters• Performed medical review of essential study documents developed by Medical Writers• Participated in the development of study-specific safety management and medical monitoring plans• Delivered trainings to the investigators and project teams in the study protocol and/or therapeutic area within the assigned studies• Provided medical review of the SAE narratives, supported the PVG group with the SAE medical queries• Participated in Feasibility research• Participated in the DSMB/DMC meetings• Performed medical review of the clinical data base (listings, profiles)
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Senior Clinical Research AssociatePsi Cro Ag Jan 2008 - Dec 2008Zug, Ch• Prepared, conducted and reported site selection, initiation, routine monitoring and closeout visits• Monitored patient enrollment to ensure recruitment targets and project timelines are met at site level• Participated in site audits and other types of QC visits with corrective actions plan development and implementation• Delivered presentations in Investigator’s meetings and CRA trainings • Supervised daily activities of the junior CRAs
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Clinical Research AssociatePsi Cro Ag Sep 2006 - Dec 2007Zug, Ch• Acted as the main line of communication between the Sponsor and the site• Conducted site selection, site initiation, site close-out, site routine monitoring• Performed CRF review and source data verification• Communicated on ongoing basis with sites, vendors• Supported the investigators with SAE processing and follow-up; • Communicated with the project team and client when needed.• Delivered training to the site staff• Participated in site audits
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Clinical Research AssociateM&M Clinical Research Aug 2005 - Aug 2006• Conducted site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance and data completion• Communicated on ongoing basis with sites and vendors • Performed source data verification and CRF review• Reviewed data queries and listings and worked with study centers to resolve data discrepancies
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Clinical Pharmacologist (Medical Assessor)National Medicines Agency (Romania) Sep 2003 - Aug 2005RoProvided medical opinion on the Summary of Product Characteristics, Package Leaflet and the Approval of the Marketing Authorization -
InternshipCounty Hospital, Bacau Jan 2001 - Dec 2001Performed the initial assessment of the patients, and actively participated in all aspects of patient care, including initial history and physical, diagnostic and therapeutic planning, and procedures, under the supervision of senior and attending physicians
Oana Avram Skills
Oana Avram Education Details
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University Of Medicine & Pharmacy "Gr. T. Popa" IasiGeneral Medicine -
Clinical PharmacologyResidency In Clinical Pharmacology
Frequently Asked Questions about Oana Avram
What company does Oana Avram work for?
Oana Avram works for Psi Cro Ag
What is Oana Avram's role at the current company?
Oana Avram's current role is Head Medical Monitoring and Consulting @ PSI CRO.
What is Oana Avram's email address?
Oana Avram's email address is oa****@****hoo.com
What schools did Oana Avram attend?
Oana Avram attended University Of Medicine & Pharmacy "gr. T. Popa" Iasi, Clinical Pharmacology.
What skills is Oana Avram known for?
Oana Avram has skills like Leadership, Clinical Trials, Ich Gcp, Cro, Electronic Data Capture, Data Monitoring Committee Management, Ulcerative Colitis, Clinical Pharmacology, Infectious Diseases, Clinical Research, Ctms, Communication.
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