Cra 2

IQVIA; København; On-site; DKK 420,000 - 540,000; Full time

Job summary

IQVIA Denmark seeks an on-site Clinical Monitor to ensure study sites conduct and report data per protocol and regulatory standards.

Responsibilities include site visits, training, regulatory tracking, and maintaining essential documentation, with collaboration across the study team and potential involvement in start-up activities.

Qualifications

• Bachelor's Degree in a scientific discipline or health care preferred.
• At least 1 year of on-site monitoring experience.
• Knowledge of GCP and ICH guidelines.
• Strong written and verbal communication skills in English.
• Good organizational and time/financial management abilities.
• Ability to build effective working relationships with sites and study teams.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per contract and regulatory requirements.
• Coordinate subject recruitment plans with sites to support project needs.
• Administer study protocol training and maintain regular communication with sites.
• Evaluate site quality and adherence to regulations; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Maintain TMF/ISF documentation and visit reports; support project start-up as needed.
• Collaborate with study team members and assist in site financial management where applicable.

Skills

English proficiency

Organizational skills

Problem solving

Communication skills

Education

Bachelor's degree (scientific discipline/health care)

Equivalent education/experience accepted

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• 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. May support start-up phase.
• 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 GCP and local regulatory requirements.
• 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, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 1 year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

About IQVIA

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 at https://jobs.iqvia.com

Integrity

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.