Project Manager

• Aug 2020 - Present

• Project planning incl. creation of study-specific documentation, guidelines, project plans• Budgeting various study activities together with the Financial and BD Departments• Communication with the Sponsor, timely reporting on project status, coordination of investigator/hospital payments, follow-up on budget issues• Attending bid defense meetings, participating in development of proposals and client presentations• Working with the Director of Clinical Operations on building the project team• Vendor identification and management, including review of vendors’ invoices in terms of performed activities within the scope of work• Organization and running of Study Kick-off meetings, team trainings• Coordination of study logistics

Clinical Team Manager

• Aug 2019 - Aug 2020

· Planning, executing, coordinating tasks and communicating between relevant roles, such as CRAs, CTAs and global trial management, to facilitate the progress of the trial· Attending all trial related meetings / TCs and ensuring knowledge sharing across the trial team· Proactive risk identification and executing mitigation plans· Ensuring successful start-up of clinical activities (all trial related documents review, ensure timely HA/EC submission/approval, ensure materials for site initiation / selection, e.g. preparing presentations)· Budgets management· Oversight of Recruitment and Retention plans and activities· Perform Visit Report review· Conduct co-monitoring visits· CTMS set-up & update at country level· Compliance check of eTMF for assigned clinical trials in close collaboration with CTA· Supervise clinical supplies’ processes, e.g. ordering, handling ancillary, import-export process

Lead CRA (embedded in Bayer)

• Apr 2018 - Aug 2020

CRA II

• Apr 2017 - Apr 2018

CRA I

• May 2015 - Apr 2017

• Identify, select, initiate and close-out appropriate investigational sites for clinical studies• ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs applicable regulations and the principles of ICH-GCP• Motivate investigators in order to achieve recruitment targets• Deal with sponsor generated queries in a timely manner• Ensure correct archiving of files on completion of a study• Ensure IP receipt, use and return are controlled and documented• Responsible for cost effectiveness

Clinical Research Associate

• Mar 2014 - May 2015

• Perform identification, initiation, close-out and monitoring visits according to monitoring plan• Ensured that the investigator adhered to the study protocol, ICH GCP and local requirements• Manage recruitment implementing appropriate contingency plans as needed• Tracked investigators’ payments• Manage site drug supply management• Identification and report AE/SAE• Participate in feasibility studies for new proposals as required• Managed the progress of assigned studies by tracking patient enrollment, case report form completion, bio-samples shipments and data query resolution• undertaking all efforts the safety and well-being of trial subject are fully protected