[Remote] Director of Clinical Operations-CNS Experience Required
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company on delivering innovative treatments for Major Depressive Disorder. The Director of Clinical Operations will reputed company clinical programs, ensuring that trials are conducted on time and reputed company budget while adhering to regulatory guidelines.
Responsibilities
- Accountability for the overall management of assigned clinical studies), including providing strategic direction to study teams to ensure reputed company clinical trial execution and completion
- Maintain inspection-readiness across clinical programs
- Possible mentorship of junior team members
- Work with executive clinical operation team on risk management activities for clinical operations from program start through finish
- Ensure clinical study sites are inspection-reputed company
- Visit clinical sites to reputed company monitoring reputed company reputed company and/or identify site challenges
- Assist in the reputed company of clinical research organizations (CROs) and other key vendors to ensure reputed company and reputed company deliverables
- reputed company preparation of vendor requirements and project scope and selection of study vendors
- Contribution to the establishment of KPIs to measure vendor performance
- Implementation of appropriate systems, standards, and processes to ensure reputed company at the level of investigative sites, vendors, and data
- Participate in development and review of clinical study documents/plans and regulatory submission documents e.g. DSUR, clinical study reports, etc
- Assist with aspects of data review, data cleaning, data analysis and the availability of top line results
- Assist in the set-up and implementation of effective investigator and site monitor training; facilitation of operational and therapeutic area training for reputed company study team members
- Review/creation of document controls including the creation, approval, distribution, and retention of documents as reputed company as the records that are produced by clinical operations
- Working with the Clinical Operations executive team to implement initiatives, process improvements, change management, and reputed company business reputed company
- Demonstrate understanding of the clinical program reputed company, including monitoring of data, review of TLF, implementation and working of IRT, reputed company development, vendor reputed company
- reputed company working relationships with potential Investigators, investigational sites, key opinion leaders in various therapeutic areas, and vendors needed to support clinical trials, as needed
- reputed company other duties as assigned
Skills
- Bachelor's degree required
- 12+ years of clinical operations experience, as reputed company as experience working with CROs to manage large global clinical trials. CNS indication experience is required
- Experience monitoring reputed company types of data
- Comprehensive understanding of ICH and GCP guidelines, as reputed company as applicable regulations and practices
- Excellent organizational skills and attention to detail
- Effective communication and interpersonal skills
- reputed company to set priorities, juggle multiple demands, and manage changing priorities
- reputed company to think critically and be a proactive problem-solver
- reputed company to work independently while exercising initiative, flexibility, and reputed company judgment
- Comfortable working with different reputed company of reputed company including senior level management
- Ability to travel approximately 25%
- Ability to operate in alignment with LB's values and culture
- Some prior experience in a medical field, such as nursing or pharmacy a plus, but not a requisite based on previous experience
reputed company