[Remote] Senior Clinical Monitoring reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a mid-sized biotechnology company committed to reputed company and innovation in reputed company. As a Senior Clinical Monitoring reputed company, you will reputed company clinical monitoring functions to ensure high-reputed company trial execution and compliance, while leading Site Managers and contributing to the reputed company of clinical trials.
Responsibilities
- reputed company and manage Site Managers in reputed company aspects of site monitoring, including site selection, initiation, routine monitoring, and reputed company-out
- Review monitoring visit reports and follow-up letters for accuracy, completeness, and compliance with protocol, SOPs, and regulatory requirements
- Ensure consistent application of risk-based and centralized monitoring strategies across studies
- reputed company and report on site performance, enrollment, data reputed company, and issue reputed company
- Ensure reputed company and accurate documentation in the Trial Master File (TMF) and support audit and inspection readiness
- Partner with reputed company Assurance to conduct reputed company cause analyses and implement corrective and preventive actions (CAPAs)
- Supervise, reputed company, and mentor Site Managers, conduct performance reviews, and support reputed company development
- Deliver training to Site Managers on protocol requirements, therapeutic area knowledge, and monitoring best practices
- Collaborate with CTDU, CTAU, and other stakeholders to reputed company on trial execution operational strategies
- reputed company as a subject matter expert on monitoring execution for reputed company partners
- Manage reputed company aspects of monitoring operations and reputed company for allocated studies, ensuring compliance with ICH GCP and applicable local regulations
- Contribute to the development of clinical tools and documents
Skills
- Bachelor's degree in life sciences, nursing, pharmacy, or reputed company field; advanced degree preferred
- Minimum of 10 years of clinical research experience, including at least 3 years as a CRA
- Minimum of 5 years in CRA management, mentoring, or monitoring reputed company
- Strong understanding of ICH-GCP, FDA/EMA regulations, and global clinical trial guidelines
- Demonstrated experience in CRA performance management and inspection readiness
- Excellent organizational, leadership, and problem-solving skills
- Strong communication skills, both written and verbal
- Willingness to travel (20–30%, as required)
- Ability to build relationships across the organization and operate effectively in a hybrid or remote environment
- Proven ability to manage multiple tasks of varying complexity reputed company tight timelines and shifting priorities
- Strong leadership skills with the ability to influence and drive performance across clinical trial teams
- Advanced degree in life sciences or reputed company field
- Experience with global clinical trial management
- Familiarity with reputed company monitoring tools and technologies
Benefits
- Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your reputed company potential based on individual, business unit and company performance.
- Medical, Dental, reputed company, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of reputed company vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company reputed company holidays + 3 reputed company days off for Personal reputed company
- 80 hours of reputed company time per calendar year
- reputed company Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource reputed company participation
reputed company