Regulatory & Start-Up Specialist 2, Biotech, Nordic Regions

2 weeks ago

Stockholm, Stockholm, Sweden IQVIA Full time

Clinical Associate Submissions – Regulatory

Homebased

Sweden, Norway or Denmark

Job Overview

Position requires EU CTR experience for the countries, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

  • As Regulatory & Start-Up Specialist , you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.

  • You will also ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.

  • You will prepare submission documents and submit to regulatory bodies.

  • You will perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members.

  • You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.

  • Coupled with informing team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites, and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.

  • You may also act as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role.

Qualifications

  • B Sc degree in Health Sciences or related field.

  • 3 years relevant clinical research experience.

  • Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent adaptation for Nordic regions.

  • Experience in Site Contract Negotiation with Nordic sites.

  • Experience in medical device submissions beneficial.

  • In-depth knowledge of clinical systems, procedures, and corporate standards.

Skills

  • Good negotiating and communication skills in local language.

  • Knowledge of Finnish language is beneficial.

  • Effective communication, organizational, and interpersonal skills.

  • Ability to work independently and to effectively prioritize tasks.

  • Ability to manage multiple projects.

  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.

  • Understanding of regulated clinical trial environment and knowledge of drug development process.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

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