Site Start Up EUCTR I

Parexel • Hyderabad, Telangāna, India • 3w ago

Responsible for planning and submitting the simple EUCTR submissions i.e. Phase I initial submissions, Mono national initial submissions, substantial and non-substantial modification submission etc.

CORE JOB RESPONSIBILITIES:

Collaborate with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies.

Engage with Regulatory Affairs functional representatives to plan the part-II Clinical Trial Application (CTA) for EU countries.

Identify the list of Member State/countries participating in any one clinical trial and capture the information 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.

Collect 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.

Liase with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions.

Monitor and report on the progress of Part II activities to ensure alignment with overall trial timelines and objectives.

Ensure part-II CTA comply with national regulatory requirements in each member state where the trial is conducted

Triage any questions that surface (Requests For Information) as a result of capturing and/or reporting on REGN clinical trial applications and work with relevant stakeholders to have RFI responses generated.

Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submission and ensure all collected documents comply with the IVDR country requirements.

Ensure that all trial-related documents are archived in compliance with regulatory requirements and company policies.

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.

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

Job Requirements: In addition to the core duties outlined, the following qualifications are required for the Site Start Up EUCTR Level I

Interpersonal & leadership skills

Ability to understand and implement the operational strategic direction and guidance for respective clinical studies

A data driven approach to planning, executing, and problem solving

Effective communication skills via verbal, written and presentation abilities

Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

Ability to build productive study teams collaborations

Vendor management experience

Basic proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel

Experience in the clinical drug development process, including study start-up

Knowledge of ICH/GCP, EUCTR and IVDR regulatory guidelines

Basic project management skills, cross-functional team interaction and organizational skills

May require up to 25% travel

Bachelor’s degree and 1-2 years of relevant experience.

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