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 keen 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 primary 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 resolve them with minimal 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 and parental leave Apply tot his job Apply To this Job