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Senior Regulatory & Start-up / Senior CTA

International Organization founded by scientific experts and dedicated to the design and management of strategic clinical trials in oncology is looking for a Senior Clinical Trial Assistant (CTA) / Senior Regulatory Affairs in its Operations Department.

Professional career development within a growing company is being offered.

Your main goal as a Sr. Regulatory & Start-up CTA is to provide administrative and logistics support within the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, complying with international Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs). This position undertakes a variety of the daily activities of the Operations Department, focus on reports and operational documents.

Include key duties as follows:

* Coordinate the preparation, collection, distribution and tracking of study documents such as confidential disclosure agreements (CDA), Financial Disclosures, contracts, newsletters, etc

* Set-up, update and maintain clinical trial-related trackers such as regulatory documents, trial master file, start- up progress, screening/enrollment, study invoices/payments, project budgets and others as necessary;

* Prepare, maintain, and archive trial master files;

* Perform trials master file quality controls to ensure completeness and audit-readiness;

* Request, manage, distribute and track study supplies (Regulatory Binders, Study Reference Manuals & ancillary supplies);

* Distribute recruitment and other research subject-facing trial materials;

* Support on oversight of budgets and payments from customers/providers

* Support on the preparation and follow-up of audit/inspection readiness;

* Manage IRB/EC and regulatory submissions and annual reports;

* Manage regulatory submissions of Clinical Trials to EU and EEUU (highly valued)

* Coordinate, provide set up, and attend project meetings including internal team, CRO /vendor meetings, support presentations, etc.;

* Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) as applicable;

* Assist with identifying and implementing best practices and continuous improvement plans within the company;

* Perform quality checks on submission documents and site essential documents;

* Prepare and approve informed consent forms;

* Review pertinent regulations to develop proactive solutions to start-up issues and challenges

Experience

· Proven Experience of leading the coordinating of preparation of high-quality submissions to regulatory agencies for clinical trial within project timelines.

· Experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development.

· Understanding of, and ability to determine relevance of, governmental regulatory processes and regulations as pertains to investigational drug regulation.

· Project management experience and ability to work independently, supervisory experience would be an asset although not essential.

· Excellent communication skills, organization and planning skills and attention to detail.

· Must be able to communicate effectively in the English language.

SKILLS AND QUALIFICATION:

  • High education degree in a related field.
  • Based in the EU.
  • Fluent in English, both oral and written.
  • Strong interpersonal, communication, facilitation and presentation skills.
  • Strong analytical and problem-solving skills.
  • Ability to work independently and with minimal supervision.
  • Demonstrated ability to work in a small team setting.
  • Good computer skills, proficient withMS Office (Word y Excel) applications.
  • Good database management
  • Ability to communicate effectively in both official languages is an asset.

Minimum professional experience required:

3-4 years of experience of the following areas: Regulatory Affairs, Regulatory Clinical Trial Submission (Knowledge of Oncology Clinical Trials would be highly valued) and contracts.