Euctr Clinical Trial Submission Coordinator
il y a 1 jour
The CTSC collaborates with global and country teams to ensure all information and documentation for the submission to EMA Clinical Trial Information System (CTIS) are provided in a timely manner basis throughout the lifecycle of a clinical trial.
Principal Responsibilities:
1 Lead the operational EU CTR Submission strategy development, planning and delivery.
2 Set up and attend relevant trial alignment, kick-off and planning meetings with all relevant stakeholders and facilitate discussions via scenario planning with a view to agree the final EU CTR submission strategy.
4 Coordinate timely and accurate documentation, communicate submission progress and issue escalation.
5 Manage the internal systems to support EU CTR package planning and delivery.
6 Ensure required reports are generated and available for real time tracking of trial status.
7 Coordinate the RFI process in close collaboration with the internal partners.
8 Coordinate upload to CTIS.
9 Act as the primary contact person for EU CTR submissions in the Study Team.
10 Demonstrate deep knowledge of the EU CTR submissions process and CTIS requirements, provide input to trial teams.
Principal Relationships:
This position reports to the Manager EU CTR. This position will partner closely with Regulatory Affairs, GCO Regional and Country teams, Global Development, and other organizations as required.
**Qualifications**:
Education and Experience Requirements:
- Bachelor’s degree requires, advanced degree preferred.
- Minimum of 3 years’ experience working in Research & Development or Regulatory Affairs,
or related function required.
- Excellent project management, presentation and communication skills required.
- Deep understanding of EU CTR and proven track record in either EU CTR submissions or
multinational clinical trial submissions under the EU Clinical Trial Directive.
- Demonstrated experience being solutions and results oriented required.
- Ability to partner, influence and lead with a customer first mindset required.
- Ability to prioritize requests in alignment with the internal clients and propose effective
alternatives when necessary required.
- Ability to onboard new staff as CTSC.
- Demonstrated proficiency with the Microsoft Office Suite, and metric reporting and project
management tools preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
LI-ŠJ1, #LI-Hybrid
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