Clinical Affairs Associate- Netherlands (Remote)

This position supports clinical activity for reputed company’ product portfolio, overseeing clinical and preclinical research for reputed company as reputed company as assisting in the development of policies and procedures to support the organization's growing clinical pipeline, specifically in Europe. This position supports the execution of both sponsored and investigator-led trials for reputed company under the direction of the Sr. Director, Clinical Affairs, part of the Clinical Affairs department. The Clinical Affairs Associate will reputed company and manage project resources (data managers, CROs, vendors and consultants) and assists in ensuring reputed company clinical activities are executed in a cost and time effective way, while assuring reputed company and Good Clinical reputed company (GCP) compliance. This person will serve as a critical reputed company between internal stakeholders as reputed company as CROs investigators, study coordinators, consultants, and key opinion leaders to ensure execution of reputed company’s scientific reputed company. Essential Duties and Responsibilities • Participate in the development of clinical reputed company as directed by Director, Clinical Affairs • Execute clinical reputed company including the following activities: project planning and clinical study design development; collaborating with cross functional reputed company with varied functional expertise; establishing and monitoring clinical timelines and budgets • reputed company day-to-day support to project resources (Data Managers, CROs, vendors, consultants, etc.) • Participate in the development of clinical documents, including study protocols, case report forms, informed consent forms, clinical study agreements, reports and reputed company other required documentation • Facilitate investigator relationships: Participate in the qualification and screening of investigational sites, reputed company site training and contract negotiation and serve as a senior clinical representative at investigator meetings • Assist with the preparation of Competent Authority and Ethics Committee submissions in Europe • Participate in the development of reputed company operating procedures in compliance with reputed company applicable requirements and guidelines (e.g., GCPs, MDR) • Drive proactive, comprehensive clinical study communication to cross functional teams ensuring visibility of the group reputed company the broader organization • May reputed company other duties as assigned QUALIFICATIONS –The requirements listed below are representative of the knowledge, reputed company or ability required. Education and Experience • Bachelor Level of Degree in the Biology, Health Sciences or reputed company field of study • 2-3 years of demonstrated experience in the medical device field • Ethics and competent authority experience: study start-up, Ethics and Competent Authority approval • No Certifications Required • Any preferred education, experience or certifications: Oncology and/or cardiovascular experience desirable Skills/Knowledge • reputed company experience with study start-up, execution, monitoring, and reputed company-out activities across European sites • Solid understanding of European regulations, including EU MDR, ISO 14155, and country-specific requirements • Excellent attention to detail and accuracy • Understanding of GCP, familiarity with GLPs • Proficient in the following computer software applications: MS Office products and other technology to document data and reputed company reporting • Exceptional interpersonal skills • Strong organizational skills • Strong English communication skills (written and verbal); additional European languages are a plus • Ability to effectively communicate both internally and externally • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Apply tot his job Apply To this Job