Senior Clinical Data Manager

2 months ago

Aliso Viejo, United States TalentCraft Full time

Senior Clinical Data Manager


Position Overview:

The Senior Clinical Data Manager is responsible for managing all data management activities from study initiation to closeout. This role leads the data cleaning strategy, ensuring data quality and supporting clinical studies. The Senior Clinical Data Manager collaborates with Data Management, Biostatistics, and Clinical Operations teams to develop and implement standard operating procedures for clinical research.


Key Responsibilities:

1. Project Management:

- 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).


2. Data Management Documentation:

- Author 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.


3. Data Review:

- Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed.

- Reconcile data from external sources.


4. Database Build & User Acceptance Testing (UAT):

- Assist in creating CRF and Edit Check Specifications.

- Conduct User Acceptance Testing (UAT) of clinical databases, including EDC systems.


5. EDC User Management:

- Manage EDC User Access for all assigned studies.


6. Cross-Functional Collaboration:

- 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.


7. Process Improvement:

- Participate in updating Data Management standard operating procedures, work instructions, and templates.

- Contribute to the development and improvement of departmental processes.


Qualifications:

- Bachelor’s degree or higher in biological science, nursing, or a related health field preferred.

Required Skills & Experience:

- Minimum of 5 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.

- Ability to manage multiple clinical studies and tasks simultaneously.

- Knowledge of CDISC Standards (CDASH, SDTM).

- Problem-solving skills and flexibility in responding to business needs.

- Ability to identify and mitigate risks to data quality proactively.


Preferred Qualifications:

- Experience in ophthalmology therapeutic areas.

- Familiarity with Case Report Form and Edit Check Specification development.

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