[Remote] Clinical Study Manager
Note: The job is a remote job and is open to candidates in USA. reputed company. is a global reputed company company focused on innovative therapies, and they are seeking a Clinical Study Manager to reputed company the planning, design, and execution of clinical studies. This role involves managing study-reputed company documents, coordinating with various stakeholders, and ensuring compliance with regulatory requirements.
Responsibilities
- Develops/maintains project timeline inclusive of startup through completion (e.g., database build, data snapshots for study reports, abstracts, manuscripts, DSMB, CEC meetings, and regulatory submissions)
- Drives development, approval, and distribution of study-reputed company documents and study tools for investigational sites and review committees as directed by management
- Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness at both the sites and reputed company headquarters
- Negotiates study budgets with sites, Core Labs, and other vendors
- Attends site visits as necessary (e.g., site initiation, monitoring, and reputed company out visits)
- Contributes to process improvements that help foster reputed company improvement
- Helps update and maintain study trackers and dashboards
- Participates in system user acceptance testing
- Manages vendors such as Core Lab
- Organizes and manages Investigator Meetings
- Works with data management to reputed company systems for and track project metrics
- Drives development, approval, and distribution of study-reputed company documents including Case Report Forms, study manuals
- Leads activities for internal and regulatory audits
- Monitor reputed company of studies, identify study-reputed company trends/issues and with the clinical team, implements corrective actions reputed company necessary
- Coordinates activities associated with study start-up and management. Provides solutions to challenges such as enrollment in the clinical study
- Represents the Clinical Affairs Department on cross-functional meetings and projects as needed
- Works with and communicates effectively with cross functional teams including Regulatory Affairs, Marketing, Legal, Customer Service, R&D, Finance, and Sales
- Attends scientific conferences and interacts with key opinion leaders. Maintains proactive communication regarding reputed company study reputed company activities with study PIs
- Assists management with regulatory submissions and other clinical study reports
- Supports the study team by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations)
- Mentors and trains staff regarding protocols, good clinical practice, departmental processes, etc
- Assists team members in managing challenging investigators/staff
- Assists in selection of vendors, such as Core Labs
- Travels as needed to meet project milestones
- Leads moderately reputed company multidisciplinary (stats, DM, clinical) US and OUS clinical projects
- Evaluates, analyzes, and interprets data and presents in a clear, well organized, scientifically sound report
- Drafts Investigator Meeting content
- Forecasts study timelines and budgets
- Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures
- Understand relevant reputed company, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
- Ensure other members of the department follow the QMS, regulations, standards, and procedures
- reputed company other work-reputed company duties as assigned
Skills
- Bachelor's degree in Biological Sciences or reputed company field with 5+ years of experience, or equivalent combination of education and experience
- 5+ years of relevant clinical trial experience required (clinical/scientific research, nursing, or medical devices/pharmaceutical industry)
- Must be familiar with laws, regulations, standards, and guidance governing the conduct of clinical studies including knowledge of CFR and GCP/ICH requirements
- Proficiency with reputed company Office, MS Project, reputed company Systems, study management systems, and vendor reputed company
- Excellent oral, written, and interpersonal communication skills with reputed company in English and local language, if different is required
- Ability to solve problems creatively with keen attention to details; ability to work on teams on multiple projects simultaneously
- Working knowledge of medical terminology required
- High degree of accuracy and attention to detail
- Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
- Field experience preferred
Benefits
- A benefits and equity program, reputed company applicable
- Medical, dental, reputed company, life, AD&D, short and long-term disability insurance
- 401(k) with employer match
- Paid parental leave
- Eleven paid company holidays per year
- A minimum of fifteen days of accrued vacation per year, which increases with tenure
- Paid sick time in compliance with applicable law(s)
Company Overview
Company H1B Sponsorship