Strong knowledge of FDA regulations and ICH-GCP guidelines
Thorough knowledge of the clinical research process
Strong interpersonal skills for effective communication with various stakeholders
Ability to identify issues and recommend solutions independently
Strong organizational and time management skills with cross-functional collaboration
Responsibilities
Execute data management activities in compliance with ICH/GCP guidelines
Develop and approve data management documents like Data Management Plans
Design and develop Electronic Data Capture systems
Oversee and coordinate Electronic Data Capture integrations
Maintain a standard Case Report Form library
Provide expertise for trial document development
Identify and manage risks in data management
Develop DM SOPs with Clinical Operations and Quality Assurance
Manage external service providers for data management
Represent data management in regulatory authority interactions
Apply industry best practices to data management systems
Lead, train, and mentor data management personnel
Benefits
Health Care Plan (Medical, Dental & Vision)
Company 401k match up to 4%
Paid Time Off (Vacation & Sick)
Holidays
Stock Option
Full Job Description
Requirements
Some required skills for the Scientist position:
Strong knowledge of FDA regulations and ICH-GCP guidelines
Thorough knowledge of the clinical research process
Strong interpersonal skills with the ability to effectively communicate cross-functionally at all levels of the organization, as well as externally with stakeholders and ESPs
Ability to identify issues and independently assess and recommend specific solutions
Strong organizational skills, prioritization, time management, and cross functional collaboration
Primary Roles and Responsibilities:
Successful and timely execution of DM activities and deliverables in compliance with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)
Develops and/or approves DM documents (e.g., Data Management Plan, Data Transfer Agreements, Data Review Plans, etc.)
Designs and develops Electronic Data Capture (EDC)
Oversees and coordinates EDC integrations
Develops and maintains standard Case Report Form library
Provides subject matter expertise to the development of other trial documents (e.g., Protocols, Monitoring Plans, Statistical Analysis Plans, Clinical Study Reports, etc.)
Proactively identifies, mitigates, and manages risk in data management issues.
Develops and implements DM SOPs in partnership with Clinical Operations and Quality Assurance
Manages DM external service providers (ESPs)
Represents DM in interactions with regulatory authorities, as needed
Applies current industry best practices to DM systems and processes
Leads, trains and mentors DM personnel
Performs other duties as assigned
Qualifications:
BA/BS in life sciences relevant field, preferable.
