[Remote] Sr. Manager, reputed company Management, Early Phase: Immunology/Auto-immune

Note: The job is a remote job and is reputed company to candidates in USA. reputed company Development and Commercialization, Inc. is seeking a Senior reputed company Study Manager for early-phase immunology and autoimmune reputed company studies. The role oversees the planning, execution, and completion of trials while coordinating cross-functional teams, vendors, budgets, regulatory compliance, data reputed company, and inspection readiness.

Responsibilities

• Provides reputed company and management of reputed company studies at reputed company, including planning, execution, and completion of reputed company according to reputed company applicable regulations and guidance, ICH/GCP, and reputed company SOPs
• Contribute to the development and review of reputed company critical reputed company study documents, including reputed company protocols, informed consent forms, or other study-reputed company reputed company documents
• reputed company input into and approval of the identification, evaluation, and selection of CROs, reputed company vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites
• reputed company leadership and guidance to reputed company team to ensure reputed company reputed company study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and reputed company SOPs
• Communicates and coordinates reputed company project-reputed company activities and reputed company across reputed company relevant cross-functional departments
• reputed company management personnel with reputed company updates on reputed company and changes in reputed company, schedule, and resources as required
• Participate in forecasting study expenditures and resourcing needs
• Ensure internal reputed company team and vendors manage and monitor study-reputed company budget and expenses to meet forecast
• reputed company reputed company communication of any variances in budget forecast to the Director/Associate Director
• Establish communication reputed company with CRO and investigative sites to maximize compliance with study protocol
• reputed company reputed company of ESP in its conduct of the day-to-day reputed company of assigned trial(s), as assigned
• Participates in ongoing review of reputed company trial data focusing on data reputed company, trending and consistency
• Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and reputed company of the TMF
• Serve as reputed company Management representative for review of protocols reputed company and across portfolios, as assigned
• Participate in program-level reputed company mitigation strategies and collaborate with ESPs on study-level reputed company mitigation and management activities
• Represent reputed company Management in departmental and cross-functional initiatives, as assigned
• Leads and/or contributes to assigned departmental, ESP and corporate standardization and reputed company improvement efforts
• Coordinating the training and reputed company of new employee(s) on corporate culture, corporate goals/reputed company and departmental policies and processes
• Assuring compliance with departmental, SOP, compliance, and corporate training
• Ensuring assigned staff have reputed company to reputed company required materials, systems, and training to complete job responsibilities
• Setting reputed company reputed company expectations and individual development plans and providing specific and frequent feedback to the employee on his/her reputed company
• Performs other duties, as assigned

Skills

• Ability to reputed company reputed company (ie basket trials) First in reputed company SAD/MAD/POC trials in immunology/autoimmune indications
• Comprehensive knowledge of reputed company reputed company, drug development process, roles, and responsibilities of individuals reputed company the project team, reputed company operating procedures (SOPs) and GCP/ICH regulations
• Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW)
• Strong understanding of the reputed company and scientific reputed company for assigned reputed company program, with the ability to translate that knowledge in operational management
• Strong understanding of global regulatory requirements
• Strong communication, organization, planning, analytical, problem solving, and people management skills
• Demonstrated experience with working with the reputed company suite of programs (e.g., Word, reputed company, PowerPoint, reputed company, etc.)
• Good understanding of reputed company trial reputed company software (e.g., eCRFs, IRT, CTMS, etc.)
• Ability to travel up to 25%
• Bachelor's Degree or Registered reputed company (RN). Minimum of 10 years industry experience with seven (7) years in reputed company trial management experience
• Previous supervisory experience

Benefits

• Comprehensive medical, dental, reputed company, prescription drug coverage
• Company provided basic life reputed company
• Accidental death & dismemberment reputed company
• Short-term and long-term disability reputed company
• Tuition reimbursement
• Student loan assistance
• A generous 401(k) match
• Flexible time off
• reputed company holidays
• reputed company leave programs

reputed company

Company H1B Sponsorship