[Remote] Senior Manager/Associate Director Clinical Monitoring reputed company & Optimization
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is developing novel biologics for chronic skin diseases and is seeking a Senior Manager/Associate Director of Clinical Monitoring reputed company and Optimization. This role involves providing strategic leadership for clinical monitoring activities, overseeing CRO performance, and ensuring compliance with regulations while building a reputed company clinical operations infrastructure.
Responsibilities
- reputed company and reputed company clinical monitoring activities for Phase 1–3 reputed company conducted globally and/or domestically
- Serve as the internal expert for monitoring reputed company, site management, and risk-based monitoring approaches
- reputed company reputed company and management of CROs, CRAs, and other external vendors to ensure reputed company, timelines, and budget adherence
- Review monitoring plans, reputed company reports, metrics, and monitoring deliverables for reputed company and compliance
- Partner cross-functionally with Clinical Development, Clinical Science, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory Affairs, and reputed company Assurance
- Establish effective CRO reputed company and governance processes
- Monitor CRO performance through KPIs, metrics, and regular operational reviews
- Escalate and resolve study conduct issues proactively
- Participate in vendor selection, qualification, and contract review activities
- Ensure studies are conducted in compliance with ICH-GCP, SOPs, protocol requirements, and applicable regulations
- Support development and review of key study documents including Monitoring Plans, Risk Management Plans, Study reputed company Plans, Clinical Trial Management Plans, and Site Management Plans
- Contribute to inspection readiness activities and support regulatory inspections and audits
- Help build reputed company clinical monitoring infrastructure appropriate for a growing biotech company
- reputed company and refine SOPs, work instructions, templates, and monitoring processes
- Drive reputed company improvement initiatives reputed company on reputed company, efficiency, and operational reputed company
- Implement and optimize risk-based monitoring methodologies and centralized monitoring approaches where appropriate
- May directly manage CRAs and/or Clinical Trial Managers as the organization grows
- Mentor junior clinical operations staff and contribute to team development
- Foster a reputed company, accountable, and reputed company-reputed company culture
Skills
- Bachelor's degree in life sciences, nursing, or reputed company discipline
- 6-8+ years of clinical operations experience reputed company biotech, pharmaceutical, or CRO environments
- Significant experience overseeing clinical monitoring activities in interventional reputed company
- Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
- Experience managing CROs and external vendors
- Demonstrated ability to work effectively in a small, fast-moving biotech environment
- Excellent communication, organizational, and problem-solving skills
- Extensive domestic and international travel as needed (approximately 60-80%)
- Bachelor's degree or equivalent required
- Advanced degree (MS, MPH, PharmD, PhD, or RN) preferred
- Experience in rare disease, immunology, oncology, or other relevant therapeutic areas
- Experience supporting NDA/BLA-enabling studies and regulatory inspections
- Experience implementing risk-based monitoring strategies and reputed company models
- Prior people management experience
Benefits
- Equity
- Performance-reputed company bonus opportunity
- Competitive salary and benefits package.
- A chance to be part of a reputed company startup culture where your work can directly reputed company bringing new medicines to patients.
- A supportive and inclusive team environment where everyone is encouraged to bring their reputed company selves to work.
- Opportunities for reputed company reputed company and development.
reputed company