Regulatory and Site Services Specialist

Chiltern Ver Empresa

Não especificado
Licenciatura

Established in the UK in 1982, Chiltern is leading privately owned global CRO with 4200 employees located around the world. Chiltern has extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery. Chiltern is a CRO that starts every project by taking the time to understand each sponsor’s situation. Then we draw on a wide-ranging skill set to craft a customized engagement perfectly matched to those needs from start to finish.

Our successful and dynamic team in Portugal is currently looking to expand.

Are you searching for an exciting new role? Do you have any experience in start-up and regulatory affairs? Then this is a fantastic opportunity for you!

We are looking to recruit Regulatory and Site Services Specialist office based in Portugal.

About the department: This department provides an efficient, quality-centric approach to study startup activities with a growing focus on site relationships. RSS perform regulatory and ethics submissions (initial and amendment), document collection and quality control through all phases of the clinical trial, and execution of site level feasibility in coordination with the Feasibility department. There are opportunities to develop your career, take on more responsibilities and be involved in cutting edge global studies.

Duties & Responsibilities:

  • Support the RSS team where applicable with regulatory and ethics submissions subject to resource needs e.g. non-substantial amendment submissions.
  • Assist in the development of Informed Consent Forms, labels and other patient facing material in accordance with country-specific requirements.
  • Coordinate and/or perform the preparation, quality control review, and submission of CTA packages including initial submission, amendments and End of Trial Declarations as well as non-substantial notifications, status reports etc. to the CA and IRB/IECs and to any other country specific authority/body in assigned countries (except FDA).
  • Prepare and respond to Competent Authority (CA) and Ethics Committee (EC)/Institutional review Boards (IRB) and to any other country-specific authority/body after Regulatory Project Lead/Manager approval.
  • Develop and produce metrics and status reports to support the needs of Project Managers, line management, and other senior-level department colleagues.
  • Facilitate/participate in training programs and department meetings.
  • Provide input to Requests For Information (RFIs), Requests for Proposals (RFPs) and bid defence presentations as required.

Requirements:

  • Bachelor’s degree in life sciences, related discipline or experience in the role.
  • Proven working knowledge of Study Start Up activities and Document submission
  • Experience of the clinical research process and terminology
  • Experience using a clinical trial management system
  • The successful candidate will be a strong communicator, who has a great eye for detail and excellent organizational skills. You will have the ability to work independently and as a part of a team.

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