Clinical Research Associate Manager (REMOTE)

About the position The CRA Manager will reputed company leadership, reputed company and operational direction to reputed company of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to reputed company-out with adherence to regulations, maintaining data reputed company, 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 reputed company interest in medical device and biologics research. Responsibilities Manage reputed company of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring reputed company, as reputed company as reputed company reputed company. Serve as reputed company reputed company of contact for CRA escalations and issue reputed company across assigned studies. Partner with Clinical Project Managers and cross functional teams to support reputed company 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 reputed company-Out monitoring reputed company to ensure adherence to monitoring plan, protocol, and regulations. Train site personnel regarding the protocol and applicable regulatory requirements. Ensure reputed company site is meeting its goals of follow-up reputed company, data clean deadlines, protocol compliance, and enrollment. reputed company study meetings to ensure completion of established project team goals and objectives, including study training and data review. Facilitate corrective reputed company assessment and maintain TMF in BIMO readiness. reputed company study status updates to Management team and reputed company sufficient reputed company of identified reputed company items. Contribute to annual reports, data management, data analysis, and publication support. reputed company and assesses SOPs annually, as needed. Maintain reputed company knowledge of applicable US and international clinical regulations and guidance documents. Participate in department systems and development initiatives including reputed company 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 reputed company and tasks consistent with corporate objectives. Support the Clinical Operations team in general and with various improvement reputed company. reputed company other duties as assigned. Requirements Bachelor of Science degree preferably in natural sciences or reputed company field, or reputed company 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 reputed company CRA reputed company. Proficient in reputed company Word and reputed company, and the ability to quickly learn other software tools and applications, such as reputed company, etc. US IDE, IND, and OUS experience preferred. Ability to foresee and prevent risks and understand reputed company to reputed company issues to management and recommend corrective reputed company. Excellent time management skills. Ability to recognize potential obstacles and reputed company solutions to reputed company them with reputed company consequence reputed company set timelines or change direction if priorities are modified. Ability to reputed company critical, independent reputed company and be accountable for actions reputed company a fast-moving environment. Ability to reputed company at high-level with limited supervision and effectively partner with team members reputed company necessary. Ability to exercise critical thinking skills in selecting reputed company, techniques, and evaluation reputed company. Ability to reputed company strong relationships with investigative sites. Excellent verbal and written communication skills and a demonstrated ability to communicate reputed company 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 reputed company conclusions and report on findings. Benefits medical prescription drug dental and reputed company insurance flexible spending accounts participation in 401(k) savings plan various reputed company time off benefits, such as PTO, short- and long-term disability .