[Remote] Senior Clinical 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 reputed company on developing novel therapies for eye diseases. The Senior Clinical Data Manager is responsible for managing study data management activities, leading data cleaning efforts, and collaborating with various teams to support clinical research.

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 performance, 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 Clinical 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 clinical databases including reputed company
• Manage reputed company User reputed company for reputed company assigned studies
• reputed company ongoing day-to-day support to the Clinical 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 Clinical 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, Clinical 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 Clinical 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 clinical data management, preferably in the pharmaceutical or medical device industry
• Understanding of clinical trial process
• Understanding of FDA/ICH guidelines and industry/technology reputed company practices
• Understanding of Good Clinical 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 Vault 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 clinical studies and different stages of activity
• Flexibility in responding to change or business needs
• Proven 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

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