If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Site Start Up EUCTR III (Senior iCRA), home-based and sponsor dedicated, in Serbia.
In this role you will be responsible for planning and submitting the European Union Clinical Trials Regulation (EUCTR) Part II application according to the requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management, Clinical Trial Transparency team and CRO will be core to the role.
We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.
As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.
You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.
The most significant aspect of this position is
- Responsible for planning and submitting all EUCTR submissions at program level, ensure alignment across studies and contribute to defining the program level submission strategies.
- Stay updated on changes in regulations and industry best practices to contribute to continuous improvement of Part II processes and procedures.
- Responsible for developing and maintaining EUCTR job aid documents to support team members in understanding and executing EUCTR submission requirements and tasks effectively.
- 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.
From you we expect
Bachelor degree
Minimum 4 years experience in EUCTR submissions
Demonstrated 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 influence and negotiate across key stakeholders
Ability to build productive study teams collaborations
Demonstrated vendor management experience
Technical 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
Effective project management skills, cross-functional team interaction and organizational skills
May require up to 25% travel
We will offer you
Premium salary.
Attractive benefits.
Medical care plan: Health, Dental & Vision.
Life Assurance.
Excellent work environment.
Culture of teamwork and collaboration.
People who motivate and face challenges together.
Innovative technology.
Excellent training.
For an immediate interview please apply or contact marta.kuniewicz@parexel.com
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