Andreea Bodea Email & Phone Number

Ilfov County, Romania

• Prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities.• Compile the application package for clinical trials in compliance with project scope and regulatory requirements.• Act as local regulatory contact and regulatory lead for assigned studies.

Bucharest, Romania

• Prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities.• Compile the application package for clinical trials in compliance with project scope and regulatory requirements.• Act as local regulatory contact and regulatory lead for assigned studies.

• Develop and assist with the implementation of the Central File specifications.• Ensure Central File project specifications details are consistent with program level plans and milestones.• Ensure consistent use of standardized processes and technologies across programs.• Serve as a point of contact for internal and external audits of Central File related processes and activities.• Review document quality data and audit outputs to identify trends across the programs to ensure… Show more • Develop and assist with the implementation of the Central File specifications.• Ensure Central File project specifications details are consistent with program level plans and milestones.• Ensure consistent use of standardized processes and technologies across programs.• Serve as a point of contact for internal and external audits of Central File related processes and activities.• Review document quality data and audit outputs to identify trends across the programs to ensure quality documentation.• Actively identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.• Review metrics to monitor performance against targets to ensure program deliverables are being met and productivity is aligned with expectations.• Work with Manager to develop resource strategies to achieve program goals.• Support study team to ensure document quality requirements and timelines are met.• Support study team in addressing queries pertaining to document management.• Ensure complete Central Files in place at time of study close. Show less

• Responsibilities include creation, maintenance, and archive of clinical trial master files in accordance with PAREXEL Standard Operating Procedure (SOP), GCP, and FDA regulations. • Maintain PAREXEL’s electronic document management system, and ensure quality and content of paper and electronic central files. • Support project team to ensure that proper documents are received and submitted in a timely matter.• Support project team for internal and external audits.

• Registration of contracts and performing ongoing contracts changes;• Handling of renewal process;• Ensure that policies, legal regulations and audit requirements are met;• Translation of customer requests;• Coordinate and manage structured and high quality communication to both end-users and internal colleagues.

Licenta, Limbi Straine: Franceza- Portugheza

Bacalaureat, Filologie