Study Start-Up Associate Site Manager with French language

Associate Site Manager Study Start-Up

Real-World Evidence

Hybrid: Bulgaria, Hungary, Serbia, Romania

IQVIA Real-World Evidence (RWE) teams work with clients to help them collect and use real-world data to generate evidence to meet the needs of regulators, payers, providers, and patients.

Our approach is unique in the industry and is defining the way companies develop and apply real-world evidence for healthcare decision making.

We are collaborative, intellectually curious, entrepreneurial, and constantly looking for opportunities to harness the value of real-world evidence in an evolving industry.

Due to continued growth, we are seeking new brave minds to join our award winning and innovative department.

Main Responsibilities

Site Selection:

• Contact the sites to know their interest to participate in the study.
• Collect some documents like signed Confidential Disclosure Agreement.
• Support the Site for Site Information Form completion (questions about site interest, capacity, submission, SSU timelines, enrolment target).
• Update all information in internal applications.

Ethic Committee Submission & Contract Negotiation with sites:

• Collect all documents (Signed Protocol Signature Page, CV, etc.).
• Communicate with sites.
• Provide to study team EC timelines, meeting date, documents required for the submission.
• Informed Consent Form Country Adaptation.
• Complete Application form (questions about the study, study type, timelines, doctor list).
• Prepare draft Contract for Site.
• Customize the cover letter for EC submission (Letter to the EC with all study information, document list).
• Communicate with EC (Answer to EC questions, ask them for timelines).
• Update all information.
• Prepare and negotiate Contract with site

Qualifications

• Bachelor's Degree preferably in life science/ health care, or equivalent combination of education, training, and experience.
• Prior relevant experience will be an asset.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is preferred.
• Excellent written and verbal communication skills including good command of English & French language (C1 level).
• Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint.
• Organizational, planning, interpersonal, and problem-solving skills.
• Strong attention to detail.
• Time management skills.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients and site personnel at assigned sites.

What is in it for you?

• Global exposure
• Variety of therapeutic areas
• Collaborative and supportive team environment
• Access to cutting-edge in-house technology
• Excellent career development and progression opportunities
• Work-Life Balance

JOIN US

• Embrace your curiosity and grow your career in an exciting environment where development is a priority.
• Think boldly and disrupt conventional thinking.
• Enjoy what you do.