GEHC - Clinical Data Manager III

Title Data Manager
Number of Leased Workers needed 1
Tentative start date asap
Tentative end date 12 Months
Work shift (days/times) 1st Shift
Work Location 100% Remote
Travel Required (% of travel) No
Is this a temp to perm position contract

Job Description Summary

As a Clinical Research Data Manager, you will be responsible for supporting medical device clinical trials and research through coordinating, facilitating, and participating in all data management activities from initiation of a study protocol, through final data archival. In this role, you will partner with Clinical Operations teams (Study Monitors, Statisticians, System Admin) and Clinical Research Managers to ensure strategic planning, resourcing, execution, and oversight of clinical trial data deliverables.

Essential Responsibilities
Serve as the primary point of contact for all data management activities for multiple clinical trials across a range of medical devices and program teams ensuring compliance with Good Clinical Practices, ISO 14155 and other applicable regulations.
Works with Clinical Operations and Clinical Research Managers to ensure data management activities are conducted compliantly and according to project timelines.
Attends internal and external meetings as necessary to facilitate discussion and decisions for data management strategy pertaining to study, regulatory, or GCP specific requirements
Develops and maintains study-specific Data Management Documents, such as DMPs, DVPs, CCGs and CRFs based on protocol and study requirements
Builds clinical trial databases from data specifications, including edit checks, derivations, and Custom Functions.
Consults and collaborates with the Clinical Research Operations Team to review reporting needs and develops reporting mechanisms
Keeps management informed on progress and other project related information, assist management in projecting resources, and perform administrative duties as requested.
Participates in team review and maintenance of QMS work instructions governing Clinical Data Management, always striving to identify and implement opportunities for improvement.

Qualifications/Requirements
Bachelor s degree, preferred in analytic discipline (Computer Science or Health related field) or high school diploma/GED with 6+ years in Pharmaceutical/Biotechnology industry
Experience working with Data Management in the Clinical Trial industry (preferably medical device) that includes an understanding of regulations and laws over data privacy
Experience working with Electronic Data Capture (EDC) that includes building, validating, and decommissioning clinical databases
Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages
Working knowledge of clinical research operations and documentation
Desired Characteristics
Prior experience utilizing Veeva CDMS or RedCap
Prior experience designing in Architect
Prior experience designing Custom Functions using C#
Prior experience building dashboards using Business Intelligence tools (e.g., Business Objects, Power BI, Spotfire, Tableau)
At least 2 years of experience in at least one programming language (e.g., C#, Java, XML)
Well organized and structured, high attention to detail.
Knowledge of Quality Management Systems (QMS) including experience with GDP and CAPA
Excellent oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
Proven ability to drive multiple projects and initiatives in a cross functional environment while leveraging key stakeholders and engaging end users
Proficiency in database design/management, programing languages, clinical data management tools, and MS Office