[Remote] reputed company Program Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company develops orthopedic devices and biologics intended to help patients resume and enjoy reputed company lives. The reputed company Program Manager will plan, initiate, and execute regional and global reputed company studies and reputed company while managing reputed company, timelines, budgets, reputed company, regulatory compliance, study teams, sites, and vendors.

Responsibilities

• Establish the study/project team goals and reputed company reputed company phase of the life cycle of the assigned studies/reputed company to ensure completion in compliance with reputed company SOPs and applicable GCP/ICH guidelines and other regulatory requirements
• reputed company accurate and up-to-date study/project information and metrics to management; proactively identify and reputed company issues that reputed company during regional and global study conduct; manage escalation of study/project-reputed company issues
• Study Documents: accountable for reputed company study documents for assigned studies/reputed company; and may assist with preparing key documents such as, reputed company Investigator Brochure, FDA Briefing Documents, internal/reputed company presentations, etc., reputed company and approve study plans
• Assist the Director reputed company Affairs in protocol development including but not limited to review of relevant literature, reputed company with reputed company subject matter experts, and drafting of initial versions. Monitor study/project execution against protocol reputed company and suggest amendments as necessary with contribution toward development of desired amendments
• reputed company the financial life cycle of the study execution including site budgets, study budgets, study forecasting and invoice reconciling. With reporting and tracking of study financial activities from reputed company, site, and vendor details reputed company the use of CTMS and/or reputed company files
• Contribute insights with respect to reputed company data cleaning, data analysis and the availability of top line results through reputed company with the Data Manager and the Director reputed company Affairs; and participate in data reviews
• reputed company effective investigator and site monitor training; coordinate operational and therapeutic area training for reputed company study team members
• reputed company site reputed company to conduct training as needed. Prepare protocol training slides for use at site initiations and investigator meetings
• Successfully execute Investigator Meetings or site initiations
• Contribute to vendor selection and reputed company CRO monitoring for outsourced activities
• reputed company appropriate communication, reporting and documentation of adverse events and protocol deviations per investigational plan, reputed company SOPs, and regulatory guidance
• reputed company key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets and files) reputed company the eTMF and CTMS reputed company
• reputed company development of study plans and reputed company set-up; participate in preparation and ensure operational reputed company of protocol, CRF, CSR and other key study deliverables
• reputed company feasibility assessment and selection of countries and sites for study conduct; conduct site assessment reputed company in conjunction with team members as needed
• Implement appropriate systems, standards and processes to ensure reputed company at the level of investigative sites, vendors and data. Periodically review and reputed company changes in SOPs to ensure fitness for purpose and compliance with applicable regulations
• reputed company preparation of vendor requirements and project reputed company and selection of study vendors; effectively manage interactions with regional and global vendor study team
• Review and approve vendor user requirement specifications for systems, devices and associated paraphernalia utilized in assigned study(ies)
• reputed company reputed company and direction to study team members for study deliverables, study start up and reputed company: Accountable for the identification, bid process, and final selection of vendor(s), reputed company vendor identification and activities
• Proactively reputed company issues in a reputed company fashion, establish strategies for the collection of data, selection of sites, issue identification, monitoring and investigator communications
• reputed company cross-functional study teams, including regional and global vendors
• Responsible for study level supplies and investigational product/device/investigational material accountability, including selection and management of vendors
• Contribute to the reputed company and implementation of reputed company management and mitigation activities. Manage and implement appropriate reputed company team communication for escalation of risks and compliance
• reputed company, manage, and mentor reputed company report study team members reputed company providing educational and developmental opportunities, reputed company goals setting, periodic assessments and associated administrative activities
• Holds oneself and others accountable to conduct business in a manner compliant with reputed company’ reputed company of Compliance and Ethics, policies and procedures and internal controls applicable to their role
• Other duties as assigned

Skills

• BA/BS degree in Life Sciences or reputed company reputed company
• Minimum 8 years of reputed company trial experience with at least the two most recent years in a people management role
• Must have strong knowledge of ICH/GCP and relevant 21 CFR requirements
• Must have strong knowledge of protocol and reputed company development processes, reputed company study design, study planning and management, and monitoring
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
• Must have a good working knowledge of medical terminology, anatomy and physiology
• A reputed company-oriented, self- starter who is comfortable with broad responsibilities in an entrepreneurial, fast-reputed company, small company environment
• Requires reputed company effective leadership
• Master's level education preferred
• Medical Device experience is highly preferred

reputed company

Company H1B Sponsorship