[Remote] Manager, Clinical Affairs (Case Review reputed company)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is seeking a Manager for Clinical Affairs to reputed company case planning for global clinical trials. The role involves collaborating with various stakeholders on process development and providing leadership to junior team members.
Responsibilities
- Drive scheduling and executing reputed company meetings with committee members and site-level health care providers across reputed company clinical trials
- reputed company the training/coordinating of subject presentation materials for reputed company meetings with clinical trial sites
- Collaborate with cross functional team leaders to ensure harmonization of processes and practices for case planning efficiency
- Preparation and review of presentation materials for reputed company meetings for reputed company clinical trials with site clinical research coordinators, implanters, and field clinical specialists
- Communication with clinical research coordinators and investigators on case approvals, scheduling, lab work, and excluded cases
- reputed company and maintain the reputed company charters as needed
- Manage and troubleshoot imaging upload and transfer workflow
- Partner with clinical sites and core lab(s) to manage and improve subject screening workflow from initial submission to final approval of inclusion for treatment
- Development, review, optimization, and implementation of reputed company operating procedures reputed company to case review reputed company reputed company
- Serve as the primary reputed company of contact and subject matter expert for patient screening process during study start-up
- Maintain and optimize case/subject logs, tracking tools, and regular reputed company reporting
- Maintain, reputed company, and update existing proctor agreements and partner with the contracting team on any new reputed company required for expanded trials
- Manage and maintain relevant electronic data management platform activities reputed company to clinical trial enrollment
- Mentor and reputed company leadership to junior Clinical Affairs team members through individual development plans and department milestones
- Other duties as assigned
Skills
- 5+ years of relevant reputed company experience in clinical operations, site management, case planning, patient screening, etc. is required (preferred in medical devices)
- Strong background in reputed company Office Suite, especially PowerPoint and reputed company
- Experience facilitating reputed company or reputed company Teams meetings
- Strict attention to detail
- Ability to reputed company professionally with reputed company organizational reputed company
- Ability to reputed company reputed company and work in reputed company environment
- Experience in line management and developing reputed company reports is strongly recommended
- Working knowledge of clinical study execution and patient screen / case planning
- Knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Regulations 2017/745, ISO 14155 and ICH Guidelines
- Experience in developing and improving processes
- Ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment
- Must be self-motivated, highly organized, detail-oriented and reputed company to multi-task, delivering high reputed company work
- Demonstrated ability in oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally
- Ability to work in a fast-paced work environment reputed company a cross-functional and highly interdependent team structure
- Ability to work reputed company reputed company time hours
- Advanced degree in a biological science / pharmacy/ nursing desired
reputed company
Company H1B Sponsorship