Bachelor's degree in biological science, nursing, or related health field preferred.
Minimum of 7 years in clinical data management, ideally in pharma or medical device sectors.
Solid grasp of clinical trial processes and FDA/ICH regulations.
Hands-on experience with EDC systems (MedNet, Rave, Veeva Vault EDC).
Proficient in data review and reporting/analytics tools.
Strong project management and documentation abilities, especially in drafting Data Management Plans and guidelines.
Excellent communication skills, both verbal and written.
Ability to juggle multiple clinical studies effectively.
Responsibilities
Represent Data Management in team meetings, offering metrics and guidance on data issues.
Oversee the full spectrum of Data Management activities for studies.
Develop and manage timelines, ensuring quality and timeliness of data.
Create key documents like Data Management Plans and study timelines.
Prepare training materials for various stakeholders.
Maintain audit-ready project documentation for Data Management.
Support Clinical Programmers in managing Data Transfer Agreements.
Conduct regular data reviews to identify quality issues and trends.
Benefits
Comprehensive healthcare coverage for employees and dependents.
401(k) retirement plan with company matching contributions.
Professional development opportunities and support for certifications.
Flexible working hours and options for remote work.
Generous paid time off and holiday policies.
Full Job Description
Responsibilities:
Represent Data Management in study team meetings, providing metrics and guidance on data-related issues.
Oversee Data Management activities from study start-up to close-out.
Develop and manage study timelines and ensure the quality and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders).
uthor key documents, including Data Management Plans, Data Review Guidelines, eCRF Completion Guidelines, and study timelines.
Prepare training materials for Investigator Meetings, internal teams, and site staff.
Maintain all Data Management project documentation in an audit-ready manner.
Support Lead Clinical Programmers in developing and managing Data Transfer Agreements.
Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed.
Reconcile data from external sources.
ssist in creating CRF and Edit Check Specifications.
User Acceptance Testing (UAT) of clinical databases, including EDC systems.
Manage EDC User Access for all assigned studies.
Provide day-to-day support to Clinical Study Teams to ensure data is reviewed and discrepancies are resolved.
Collaborate with internal stakeholders to meet study timelines and deliverables.
Work with Clinical Programming to produce reports for efficient data review and cleaning.
Facilitate cross-functional Data Management meetings with Study Managers, Project Managers, Programming, and Regulatory teams.
Review study protocols and provide feedback on data collection methods.
Participate in updating Data Management standard operating procedures, work instructions, and templates.
Contribute to the development and improvement of departmental processes.
Requirements:
Bachelor's degree or higher in biological science, nursing, or a related health field preferred.
Minimum of 7 years of experience in clinical data management, preferably within the pharmaceutical or medical device industry.
Strong understanding of clinical trial processes, FDA/ICH guidelines, and Good Clinical Data Management Practices (GCDMP).
Hands-on experience with Electronic Data Capture (EDC) systems such as MedNet, Rave, and Veeva Vault EDC.
Proficiency in data review and use of reporting/analytics tools.
Excellent project management and documentation skills, with experience writing Data Management Plans, Data Review Guidelines, and study timelines.
Strong verbal and written communication skills.
bility to manage multiple clinical studies and tasks simultaneously.
Knowledge of CDISC Standards (CDASH, SDTM).
Problem-solving skills and flexibility in responding to business needs.
bility to identify and mitigate risks to data quality proactively.
Experience in ophthalmology therapeutic areas.
Familiarity with Case Report Form and Edit Check Specification development.
