Clinical Research Manager (87TL) Bothell, Washington
Verathon is a wholly owned subsidiary of Roper Industries, an acquisitive S&P 500 and NYSE listed diversified growth company. Verathon is headquartered in the greater Seattle area, in Bothell, Washington, and has 7 international subsidiaries in Canada, Europe and Asia. The company designs, manufactures, distributes and markets reliable, state-of-the-art medical devices and services that offer a meaningful improvement in patient care to the health care community. Our largest brands, Bladderscan and Glidescope, have achieved worldwide recognition as the number one leader in their respective markets. Verathon is a financially sound company with consistent growth and performance even during down market cycles. We have a strong pipeline of new products for multiple areas of discipline within the health care industry.
We offer an entrepreneurial environment that is team-centered, customer-driven, quality-focused, and growth-oriented. Working at Verathon gives you access to challenging, “stretch” opportunities. Verathon was acquired by Roper Industries in December 2009 as a platform for future acquisitions leveraging the talented management team and excellent channel development in developed country markets.
We are seeking a talented Clinical Research Manager to work in a fast-paced, high tech, manufacturing environment. The ideal candidate will play a key role within the organization with experience in change management, and will be an advocate for continuous improvement. This position requires an innovative individual with the willingness to drive change, an ability to take calculated risks, excellent communication skills and the ability to work with a diverse group of associates and in cross functional teams and international cultures.
This position is a key position in the global Verathon clinical team. Specifically, this position is responsible for leading the clinical duties for Verathon Inc. The Clinical Research Manager will provide leadership within the clinical team and throughout the organization to enhance the growth of the company.
- Key point person in Clinical Operations for product development.
- Ensures compliance with Good Clinical Practices (GCP), regulations, SOPs and protocols.
Responsible for the planning, organizing, implementing and monitoring Significant Risk(SR), Non-Significant Risk(NSR), and Consumer Preference Testing clinical studies.
- Developing and documenting the clinical strategies
- Able to create and write SR and NSR clinical study protocols for Class I-III medical devices. Provides technical input to study designs and clinical development plans.
- Supervises the study start-up, monitoring and study close-out activities
- Monitoring compliance of studies
- Ensures accurate and complete study management/data collection and transfer into the data management system.
- Ensures site compliance with regulations and study protocol.
- Writing clinical summary closing reports
- Coordination and management of “Investigational Use Product”
- Acts as the operational and clinical interface between the sponsor and the clinical research sites which may be domestic or international.
- Works closely with the VP of Medical Affairs as part of the Core Clinical Research Team to conduct the clinical trial / study based up the highest level of professionalism and integrity consistent with good clinical practice guidelines.
- Plans, implements and executes clinical studies to support clinical claims as well as claim expansion of products; plans, implements and executes additional post-marketing clinical studies of CE-marked and FDA cleared products.
- Regularly interacts with executive management on work of area(s) that impacts larger organizational goals.
- Implements domestic and global study support strategies and initiatives.
- Supports team in FDA audits and projects as well as supporting regulatory filings (related to clinical trials).
- Supports the preparation clinical summary reports and (for internal and external customers) for product registration.
- Creates and maintains Standard Operating Procedures for the Clinical Department.
- Supports Medical Director(s) by executing budget and contract negotiations with study sites, central laboratories and CROs. Also prepares and tracks study budgets per contract.
- Maintains a high level of professional expertise through familiarity with scientific literature, product portfolio and competitive environment.
- Represents Verathon in hospitals and labs and interacts with international opinion leaders, investigators and other key customers.
- Reviews study protocols, reports and manuscripts.
- Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
- Supervises mentors and trains Clinical Research Monitors, CRAs, Senior CRAs, CRA assistants.
- Conducts direct report evaluations.
- Acquires and maintains technical knowledge of product lines.
Knowledge, Skills, and Abilities Required:
- Bachelor's Degree required.
- Preferred: RN or Masters level study life sciences such as biology or chemistry.
- 10+ years of experience in FDA/EU medical device clinical trials with a significant leadership role.
- Extensive knowledge and experience with Investigational Device Exemptions of 21CFR Part 812 and GCP’s
- Proven technical writing skills with experience writing clinical protocols and reports.
- Previous urology, women’s health, or cardiology experience, a plus.
- Ability to work in and contribute to a clinical research, medical office, and hospital base team.
- Ability to solve problems in a detailed, comprehensive manner with demonstrated urgency and energy to handle problem.
- Comfortable with having to adjust to changes in work environment, able to work under pressure with a sense of urgency, and meet tight deadlines.
- Adept at prioritizing work and coordinating tasks simultaneously.
- Motivated, self-starter; promotes positive attitude with ability to influence others. Results oriented — gets things done.
- Ability to prepare and present complex data in a simple, understandable manner.
- Strong interpersonal skills, with ability to work independently, as well as part of a team.
- Compulsive attention to detail.
- Ability to interact effectively with all levels of employees/customers and align and integrate with other departments and locations. Ability to develop strong partnership/teambuilding relationships with clinical sites and all functional areas of the business.
- Excellent written and verbal communication skills; must be good with people and managing relationships with clinical staff.
- Excellent presentation skills required.
- Competency in MSWord, Excel and PowerPoint.
- Travel domestically and internationally up to 40% of the time.
Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success.