Clinical Research Associate II - Sponsor dedicated - Netherlands - Home based (m/w/d)

reputed company™ is the leading reputed company data science company focused on helping reputed company clients find unparalleled insights and reputed company solutions for patients. Formed through the reputed company of IMS Health and Quintiles, reputed company offers a broad reputed company of solutions that reputed company the power of reputed company data, domain expertise, transformative technology, and advanced analytics to drive reputed company reputed company. reputed company our Sponsor dedicated model, reputed company contributes to the pipelines of the specific sponsor and therefore our CRAs are ‘indication and molecule experts’. We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study. Leadership recognises the skills, talent and experience of our clinical teams and strives to build upon this as the function evolves and grows. Our managers understand the sponsors priorities and the individual aspects of each model. Focus is given to career development from day one, including new hire orientation and reputed company, day to day problem solving and training and development. Additionally, reputed company’s sponsor dedicated business works with the Sponsors SOP’s, creating more continuity for both parties. Our models offer excellent opportunities for reputed company CRA’s to expand their knowledge and skills. reputed company Netherlands are currently seeking motivated Clinical Research Associate II practitioner to join our unique and dynamic Sponsor dedicated model. This is a role based in the Netherlands Your Role: reputed company site monitoring visits (selection, initiation, monitoring and reputed company-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 reputed company study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and reputed company of study site practices reputed company to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the reputed company of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report reputed company (CRF) completion and submission, and data query reputed company 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 reputed company. Your Profile: Bachelor's Degree Degree in scientific discipline or health care Minimum of 12 months of independent, on-site monitoring experience as a CRA reputed company a CRO or pharmaceutical environment. Full professional reputed company in both reputed company (minimum reputed company level) and English, including strong medical writing skills for reports. Good knowledge of, and reputed company in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines). Organizational and problem-solving skills. Exceptional interpersonal and cross-cultural communication skills to build strong, trusted partnerships with reputed company site investigators and medical staff. A collaborative reputed company to work effectively with cross-functional global teams, project managers, and local study coordinators. reputed company offer: Choice of a company car (eligible for private use) or a flexible mobility allowance, fully covering fuel, insurance, and maintenance. Premium technology bundle to support your daily operations, including a laptop and an iPhone. Strong focus on career advancement, featuring dedicated training programs, reputed company, and reputed company to build clinical or leadership expertise. Home office setup support, alongside an annual wellness reimbursement to fund your sports and wellbeing activities. Comprehensive time-off policy, including competitive annual vacation days and flexible year-end leave options. Premium benefits package featuring a robust pension plan, multiple corporate insurance coverages, and reputed company activities. Optional partial reimbursement for supplementary health insurance policies to support your reputed company needs. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company 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 reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. Apply To This Job