We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical mobile apps, in vitro diagnostics and more.
We are seeking an experienced Clinical Affairs Manager to support our clinical operations team. The Clinical Affairs Manager will participate in the planning, development and execution of clinical trials to evaluate the safety, effectiveness and performance of medical devices. Clinical Affairs Managers oversee the development of clinical reports supporting regulatory submissions and provides clinical direction to development teams. This person will establish and direct clinical operations to ensure compliance with applicable laws, regulations, and company Standard Operating Procedures (SOPs) and policies governing clinical studies. They are also responsible for ensuring all activities are in compliance with Quality System requirements.
MAJOR DUTIES OF POSITION:
- Establishes, implements and manages clinical study projects for clients.
- Directs clinical projects and activities including: resourcing; project planning and clinical study design development; collaborating with other functional groups to establish and implement strategic and tactical plans that are consistent with client objectives; establishing and monitoring clinical timelines and budgets; and communicating clinical requirements and strategies to clinical staff team members.
- Directs and provides effective communication to ensure that the clinical team understands and plans for all necessary clinical activities in order to successfully establish clinical study objectives and support required regulatory submissions.
- Oversees the development of core clinical documents, including the clinical study protocol, case report forms (CRFs), informed consent forms, clinical study agreements, and all other documentation necessary for study initiation.
- Oversees clinical staff to ensure appropriate identification and qualification of investigational sites for clinical trials.
- Oversees clinical staff to ensure appropriate preparation and submission of required documentation to Institutional Review Boards (IRBs) for approval.
- Ensures maintenance of approval throughout the duration of the study and ensures compliance to IRB reporting requirements and with national and international regulations.
- Helps to ensure appropriate training is provided to clinical investigators and staff regarding data collection and reporting requirements as necessary.
- Ensures clinical studies are conducted in compliance with the respective investigational plan and all applicable regulations, IRB requirements, and Company policies and procedures.
- Oversees data management system, including development and implementation of systems to ensure the proper recording, collection, verification, validation, processing, analysis and storage of information collected in a Clinical Study.
- Oversees operation to ensure all necessary documentation, including contract agreements are executed, signed and archived.
- Provides progress reports in compliance with federal reporting requirements to regulatory agencies, IRBs, Investigators and senior management.
- Oversees development and/or updating of clinical-specific procedures to ensure continued compliance with changing domestic and international regulatory requirements and to align with corporate policies/procedures.
- Supports Regulatory Affairs with regulatory filings/registrations when necessary, such as but not limited to: support for the development of IDE submissions, development of clinical reports for 510(k)s, De Novos, and PMAs as applicable, and clinical expertise related to FDA submission questions and literature reviews to strengthen substantial equivalence positions.
- Travel requirement: 25-50%
KNOWLEDGE AND SKILL REQUIREMENTS:
- A minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device trials
- BS or BA degree required, science or related field preferred:
- 7+ years’ experience in regulated industry with Bachelors
- 5+ years’ experience in regulated industry with Masters or other Advanced Degree
- Working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB procedures
- Accuracy, reliability, and high level of attention to detail
- Strong level of professionalism, including verbal and written skills
- Proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint
- Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments
- Familiarity with medical and anatomical terminology
- Demonstrated ability to manage projects
- Ability and willingness to travel
- Medical, Dental and Vision Benefits
- 18 Days of Paid Time-Off (PTO)
- 11 Paid Holidays
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.