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
• Review document quality data and audit outputs to identify trends across the programs to ensure quality documentation.

• 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