Are you interested in collaborating with leading pharma companies to help patients all around the world?

Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

Essential Functions

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties

• Gain experience in study procedures by working with experienced clinical staff

• Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices

• Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues

• Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution

• Under close supervision, ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) /  International Conference on Harmonization (ICH) and local regulatory requirements

• Under close supervision may support start-up phase

• Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation

• Collaborate and liaise with study team members for project execution support as appropriate

• If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred

• Prior clinical experience preferred, alternatively equivalent combination of education, training and experience may be accepted in lieu of degree

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).

• Full fluency in both German and English is required (of at least C1 Level)

• Effective organization time and financial management skills

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

• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

• Knowledge of applicable protocol requirements as provided in company training

• Availability to travel 40-60% of the working time

What you can expect:

• Resources that promote your career growth

• Leaders that support flexible work schedules

• Programs to help you build your therapeutic knowledge

• Dynamic work environments that expose you to new experiences

• Home-office, company car, accident insurance and more

We look forward to receiving your application!

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