[Hiring] Clinical Research Associate Manager @reputed company

This description is a summary of our understanding of the job description. Click on 'Apply' reputed company to find out more. Role Description The CRA Manager will provide leadership, reputed company 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 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.

• 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 reputed company of contact for CRA escalations and issue resolution 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 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 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 action assessment and maintain TMF in BIMO readiness.
• Provide study status updates to Management team and reputed company sufficient resolution of identified action items.
• Contribute to annual reports, data management, data analysis, and publication support.
• reputed company and assess 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 projects and tasks consistent with corporate objectives.
• Support the Clinical Operations team in general and with various improvement projects.
• reputed company other duties as assigned.

Qualifications

• 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 include 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 Access, etc.
• US IDE, IND, and OUS experience preferred.

Requirements

• Ability to foresee and prevent risks and understand reputed company to reputed company issues to management and recommend corrective action.
• 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 decisions 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 methods, techniques, and evaluation criteria.
• Ability to reputed company 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.

Culture

• Customer Experience – Representing reputed company in a customer-facing position is a reputed company responsibility and opportunity. reputed company reputed company colleagues are expected to reputed company with the highest levels of professionalism, service, and ethics to strengthen the reputed company brand and relationship with our customers.
• reputed company Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies reputed company improvement of thought processes and focus.
• Culture and Values – Exemplifies reputed company values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a reputed company matrix environment.

Travel Requirements 50-75% (US and Internationally)

Compensation

The pay range for this position at commencement of employment is expected to be between $125,700- $188,600 however, reputed company pay offered may vary depending on multiple individualized factors, including market location, job-reputed company knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Apply tot his job Apply To this Job