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Regulatory & Study Start Up Specialist 1

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Primary Location: Vienna, Austria Full time R1282340

Job description

Regulatory & Study Start Up Specialist 1

Job Overview


Perform tasks at country level associated with the start-up phase of clinical trials, in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. Includes also relevant activities in the maintenance phase, until end of trial.

Essential Functions:


• Serve as Single Point of Contact (SPOC) in assigned studies for investigational sites, Site Activation Manager (SAM), Project Management team, and other departments. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start-up and site activation activities according to applicable regulations, SOPs, and project instructions:

- Prepare country and site regulatory documents (Informed Consent Forms, application forms), reviewing for completeness and accuracy.

- Perform country regulatory and ethics submissions

- In co-operation with project team, answer regulatory and ethics questions

- In co-operation with other departments, prepare and negotiate clinical trial agreements and budget with investigational sites

- Prepare IP release documents and co-ordinate site activation


• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Provide local expertise to project team during initial and on-going project timeline planning.
• May have direct contact with sponsors on specific initiatives.

Qualifications
• Bachelor’s Degree in life sciences or a related field or equivalent combination of education, training and experience. Experience as study co-ordinator or CRA/CTA is an asset.
• Good negotiating and communication skills
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients

• Fluent German Language is a must.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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