When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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
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