Responsible for planning and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role.

Key Accountabilities:

Operations Management:

• Engage with Regulatory Affairs functional representatives to plan the Clinical Trial Application (CTA) for any one up and coming clinical trial that involves EU countries 

• Engage with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies 

• Coordinate with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions 

• Identify the list of Member State/countries participating in any one clinical trial and capture the information within the CTIS database 

• Identify the key study level and Member State/country level milestones that represent Study Start, Study Completion, Enrollment Start, Enrollment Completion and any potential hold/restart/cancel dates that may apply to the study and capture the relevant dates within the CTIS database 

• Identify the Institutions and Primary Investigators for each Member State/Country where the clinical trial will be conducted and capture relevant contact information within the CTIS database 

• Locate the documents that are deemed applicable at the Member State/country and/or site level for the purposes of Clinical Trial Application (CTA) submissions and upload them into the CTIS database 

• Maintain the list of participating Member States/countries, Institutions and Primary Investigator over the life cycle of the study to ensure alignment and synchronization. 

• Triage any questions that surface (RFIs, Requests For Information) as a result of capturing and/or reporting on REGN clinical trial applications 

• Engage and oversee any vendor engaged to help collect, enter and/or maintain relevant information regarding Clinical Trial Applications (CTA) via the EMA CTIS database 

Document Management:

• Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines 

• Develop a familiarity with current global regulatory submission standards. 

Compliance with Parexel Standards:

• Complies with required training curriculum  

• Completes timesheets accurately as required  

• Submits expense reports as required  

• Updates CV as required 

• Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery 

Skills:

• Working knowledge of the clinical drug development process, ICH/GCP and regulatory guidelines/directives 

• Strong familiarity with EUCTD/R and Federal Code of Regulations 

• Familiarity with Veeva Vault Clinical for CTMS and eTMF use 

• Demonstrates ability to prioritize and manage multiple projects simultaneously 

• Demonstrates effective problem solving and decision-making skills 

• Interpersonal, collaboration and stakeholder management skills  

• Good communication (written/verbal) 

• Highly organized, detail oriented 

• Ability to synthesize information and demonstrate strategic thinking 

• Self-motivated, flexible, able to follow through in a fast-paced environment, ability to meet deadlines under pressure 

• Computer skills with competency in MS suite a plus 

• May require up to 25% travel 

Knowledge and Experience: 

Minimum 1-3 years of relevant/clinical essential document review experience 

Education:

• Bachelor’s degree