Clinical Affairs Specialist-R&D
JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE
It takes a team of talented people to become one of the world’s leading providers of innovative medical devices.
AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.
We accomplish this through:
- A Commitment to the Highest Standards of Quality
- Relentless Innovation
- Operational Excellence
Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry.
We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.
The Clinical Affairs Specialist supports clinical activity for AngioDynamics product portfolio and oversees the collection of clinical and preclinical research for the company as well as assisting in the development of policies and procedures to support the organizations growing clinical pipeline. This position supports the execution of both sponsored and investigator-led trials for the company under the direction of the Sr. Manager, Clinical Operations, part of the Clinical Affairs Department. The Clinical Affairs Specialist 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 employee will serve as a critical liaison between internal stakeholders as well as investigators, study coordinators, consultants and, key opinion leaders in order to ensure execution of the scientific strategy. The essential duties and responsibilities of the Clinical Affairs Specialist include: participates in the development of clinical strategy as directed by Sr. Manager, Clinical Operations; executes clinical projects including the following activities: performs project planning and clinical study design development; collaborates with cross functional groups with varied functional expertise; establishes and monitors clinical timelines and budgets; provides day-to-day support to project resources (data managers, CRO, vendors, consultants, etc.); participates in the development of clinical documents, including study protocols, case report forms, informed consent forms, clinical study agreements, reports and all other required documentation; facilitates investigator relationships: participates in the qualification and screening of investigational sites, oversees site training and contract negotiation and serves as a senior clinical representative at investigator meetings; assists with the preparation of pre-Investigational Device Exemption (IDE) and ide submissions and other interactions with the FDA; participates in the development of standard operating procedures in compliance with all applicable requirements and guidelines (e.g., GCPA); and drives proactive, comprehensive clinical study communication to cross functional teams ensuring visibility of the group within the broader organization.
Requirements: Bachelor’s Degree in Biology, Health Sciences, or Related Field required. 24 months of experience is required in the medical device field. Direct experience in the management of clinical research service providers; excellent attention to detail and accuracy; understanding of GCP and familiarity with GLPS; proficient in the following computer software applications: MS Office products and other technology to document data and provide reporting; exceptional interpersonal skills; strong organizational skills; strong communication skills (written and verbal); 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; and ability to write routine reports and correspondence. Oncology and/or vascular experience is desirable and preferred.
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.
- Job Family 2.0 Administrative Professionals
- Job Function Clinical & Medical Affairs
- Pay Type Salary
- Required Education Bachelor’s Degree
- Marlborough, MA, USA