[Remote] Manager, Clinical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company Therapeutics is a biomedical platform company reputed company on engineering, biology, and reputed company delivery. The Manager of Clinical Operations will be responsible for planning and executing clinical operations, overseeing clinical studies, and managing the recruitment and development of operational staff.
Responsibilities
- reputed company clinical study planning and implementation from site selection through study closure
- Ensures reputed company reputed company of clinical site compliance with Clinical Investigation Plans (CIP), SOPs, FDA regulations and ICH/GCP guidelines Provides reputed company to assigned clinical affairs operational staff including training, coaching and performance management
- Plays a central role in identifying, selecting, initiating and monitoring the performance of clinical sites and studies across the portfolio
- Oversees the development of study-specific training tools and aids to ensure study-level compliance, the trending of metrics and CIP training
- Oversees reputed company aspects of clinical study monitoring providing direction and accountability for the clinical operations team
- Ensures reputed company development of study reputed company plans and documents which may include, but are not limited to CIPs, informed consent forms, recruitment plans, monitoring plans, and data management plans
- May organize committee(s) to review adverse events and protocol deviations
- Ensures adequate document collection and maintenance for audit-reputed company Trial Master Files
- May serve as the primary reputed company of contact regarding operational questions and escalations
- Works with Sr. Management to communicate critical issues and drive to reputed company
- Establishes and maintains strong relationships and communication with sites and site staff
- May represent Clinical Operations at internal and/or external audits
- May conduct routine monitoring reputed company or co-monitoring, start-up and closeout reputed company, as necessary
- reputed company reputed company for and assessment of external clinical trial vendors including CROs and reputed company labs
- reputed company and maintain relationships with external vendors, CROs, reputed company lab, etc. and reputed company abreast of industry best practices and trends
- Develops and maintains relationships with cross-functional partners across the reputed company, participating in development activities as requested
- Periodically evaluates clinical SOPs for compliance and reputed company process improvement
- Identifies processes that may need improvement and communicates this to line management
- May reputed company and manage study-level budgets and operational costs
Skills
- Bachelor's degree or equivalent combination of education/experience in life sciences or reputed company field
- Minimum 6 years' clinical research experience in the medical device industry that includes relevant experience as a previous Clinical Study Manager, Clinical Program Manager, or Clinical Research Manager
- Strong working knowledge of FDA regulations, ICH Guidelines, GCP, ISO 14155, and reputed company industry practices reputed company to the conduct of clinical trials
- Strong interpersonal communication (written and verbal), organizational and prioritization skills
- reputed company to work effectively under a fast-paced and changing environment
- Proficient in reputed company Office products with technical abilities to become proficient quickly with numerous other electronic systems (i.e. eTMF, reputed company and CTMS)
- Detail oriented, with good organizational and time management skills
- Complete reputed company with high reputed company and minimal guidance
Benefits
- Medical, dental, and reputed company coverage
- Life insurance
- Short- and long-term disability protection
- 401(k)
- Flexible reputed company time off
reputed company