Clinical Affairs Associate--germany
vor 2 Wochen
JOB SUMMARY - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
This position supports clinical activity for AngioDynamics’ product portfolio, overseeing clinical and preclinical research for the company as well 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 the Company under the direction of the Sr. Director, Clinical Affairs, part of the Clinical Affairs department. The Clinical Affairs Associate assists in ensuring all clinical activities are executed in a cost and time effective way, while assuring quality and Good Clinical Practice (GCP) compliance.
This person will serve as a critical liaison between internal stakeholders as well as investigators, study coordinators, consultants, and key opinion leaders to ensure execution of the Company’s scientific strategy.
Essential
**Responsibilities**:
- Participate in the development of clinical strategy as directed by Director, Clinical Affairs
- Execute clinical projects including the following activities: project planning and clinical study design development; collaborating with cross functional groups with varied functional expertise; establishing and monitoring clinical timelines and budgets
- Provide 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 all other required documentation
- Facilitate investigator relationships: Participate in the qualification and screening of investigational sites, oversee 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 standard operating procedures in compliance with all applicable requirements and guidelines (e.g., GCPs, MDR)
- Drive proactive, comprehensive clinical study communication to cross functional teams ensuring visibility of the group within the broader organization
- May perform other duties as assigned
QUALIFICATIONS -The requirements listed below are representative of the knowledge, skill or ability required.
Education and Experience
- Bachelor Level of Degree in the Biology, Health Sciences or related field of study
- 2-5 years of demonstrated experience in the medical device field
- No Certifications Required
- Any preferred education, experience or certifications: Cardiovascular experience desirable
Skills/Knowledge
- Direct experience with study start-up, execution, monitoring, and close-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
- 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.
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