iCRAII

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

Originally posted on Himalayas