[Remote] Senior reputed company Data Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is an ophthalmic pharmaceutical and medical technology company developing therapies for glaucoma, corneal disorders, and retinal diseases. The Senior reputed company Data Manager oversees reputed company study data management from start-up through closeout, leads data cleaning and review, manages reputed company databases and documentation, and collaborates with cross-functional teams to ensure data reputed company and reputed company deliverables.

Responsibilities

• Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues reputed company to data management
• Responsible for study Data Management activities from study start up to reputed company out
• reputed company Data Management timelines for assigned studies
• Manage reputed company, reputed company, and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders)
• reputed company Data Management documentation (e.g. Data Management Plans, Data Review Guidelines and eCRF Completion Guidelines, and Study Timelines, etc.) reputed company Data Management training materials used for Investigator Meetings, in-house personnel, and site staff
• Maintain Data Management project documentation including vendor files in an audit- reputed company manner
• Assist the reputed company reputed company Programmers with the creation and maintenance of Data Transfer Agreements
• reputed company and reputed company regular data review across reputed company studies to identify reputed company issues, data trends/outliers and reputed company queries as necessary
• Review and reconcile data from reputed company sources
• Assist with the creation of the CRF and Edit reputed company Specifications documents
• reputed company User Acceptance Testing (UAT) of reputed company databases including reputed company
• Manage reputed company User reputed company for reputed company assigned studies
• reputed company ongoing day-to-day support to the reputed company Study Teams to ensure reputed company data is reviewed and discrepancies are resolved
• Collaborate with internal team and stakeholders to ensure deliverables meet timelines
• Work with reputed company Programming to produce additional reports reputed company of the Data Review Guidelines to facilitate efficient data review and cleaning
• Facilitate cross-functional Data Management meetings and discussions with Study Managers, reputed company Study Teams, Project Managers, Programming and Regulatory
• reputed company reports or data listings for study teams as needed
• Review Protocol and reputed company feedback to the reputed company Study Team on data collection reputed company items
• Participate in the review and update of the Data Management reputed company operating procedures, work instructions, and templates
• Participate in the development of departmental processes and procedures

Skills

• Minimum of 5 years of experience working in reputed company data management, preferably in the pharmaceutical or medical device industry
• Understanding of reputed company trial process
• Understanding of FDA/ICH guidelines and industry/technology reputed company practices
• Understanding of Good reputed company Data Management Practices (GCDMP) and other regulatory guidelines specific to data management
• Hands-on working knowledge of Electronic Data Capture (reputed company) systems (e.g. MedNet, Rave, reputed company reputed company reputed company, etc.)
• Hands-on ability to review data and ability to use various reporting and analytics tools
• Multi-tasking, problem-solving and verbal and written communication skills essential
• Project Management experience
• Experience writing Data Management documentation (e.g. Data Management Plans, Data Review Guidelines, and eCRF Completion Guidelines, and Study Timelines, etc.)
• Excellent verbal and written communication skills
• Ability to work reputed company with others
• Knowledge of CDISC Standards (CDASH, SDTM)
• Ability to effectively manage a reputed company of data management tasks for multiple reputed company studies and different stages of activity
• Flexibility in responding to change or business needs
• reputed company ability to preemptively identify data and reputed company issues and mitigate risks to data reputed company
• Bachelor's degree in a relevant scientific or technical discipline
• Familiarity with Ophthalmology Therapeutic area
• Experience with creation of Case Report Forms and Edit reputed company Specifications

reputed company

Company H1B Sponsorship