About the position The CRA Manager will provide leadership, oversight and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to close-out with adherence to regulations, maintaining data integrity, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research. Responsibilities • Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth. • Serve as primary point of contact for CRA escalations and issue resolution across assigned studies. • Partner with Clinical Project Managers and cross functional teams to support all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools. • Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations. • Train site personnel regarding the protocol and applicable regulatory requirements. • Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment. • Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review. • Facilitate corrective action assessment and maintain TMF in BIMO readiness. • Provide study status updates to Management team and develop sufficient resolution of identified action items. • Contribute to annual reports, data management, data analysis, and publication support. • Develop and assesses SOPs annually, as needed. • Maintain current knowledge of applicable US and international clinical regulations and guidance documents. • Participate in department systems and development initiatives including related trainings. • Support investigator meetings as needed. • Support Protocol Deviation and Adverse Event review and reporting. • Maintain credentialing requirements at hospitals and clinics as needed. • Complete projects and tasks consistent with corporate objectives. • Support the Clinical Operations team in general and with various improvement projects. • Perform other duties as assigned. Requirements • Bachelor of Science degree preferably in natural sciences or related field, or related practical experience. • Minimum 8 years of clinical research experience, medical device experience preferred. This should includes a minimum of 3 years in a CRA management, or lead CRA capacity. • Proficient in arenaflex Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc. • US IDE, IND, and OUS experience preferred. • Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action. • Excellent time management skills. • Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified. • Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment. • Ability to perform at high-level with limited supervision and effectively partner with team members when necessary. • Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria. • Ability to develop strong relationships with investigative sites. • Excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally. • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. • Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. Benefits • medical • prescription drug • dental and vision insurance • flexible spending accounts • participation in 401(k) savings plan • various paid time off benefits, such as PTO, short- and long-term disability and parental leave Apply tot his job