Sr. Clinical Data Manager

Katalyst CRO; Danbury (CT); Presencial; USD 95 000 - 130 000; Tempo integral

Resumo da oferta

Katalyst CRO is seeking an experienced Data Manager to lead Data Management activities across studies from start-up to close-out. You will oversee timelines, data quality, and collaboration with external providers to ensure timely, accurate data delivery.

Responsibilities include authoring key DM documents, training staff, maintaining audit-ready records, and working with programming, regulatory, and site teams to meet study deliverables. Strong EDC experience and CDISC knowledge are required.

Qualificações

• Bachelor's degree or higher in biological science, nursing, or related health field preferred.
• Minimum of 7 years of experience in clinical data management.
• Strong understanding of 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.
• Knowledge of CDISC Standards (CDASH, SDTM).
• Experience in ophthalmology therapeutic areas.

Responsabilidades

• 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 data quality from service providers.
• 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.
• Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed.
• Reconcile data from external sources.
• Assist 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.

Conhecimentos

Communication

Project management

Data review

Analytics tools

Multitasking

Problem solving

CDISC Standards

Ophthalmology domain knowledge

Formação académica

Bachelor's degree in biological science or related health field

Ferramentas

MedNet

Rave

Veeva Vault EDC

Descrição da oferta de emprego

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).
• 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.
• Lead regular data review across studies, identifying quality issues, trends, and outliers, and generate queries as needed.
• Reconcile data from external sources.
• Assist 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.
• 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.
• Experience in ophthalmology therapeutic areas.
• Familiarity with Case Report Form and Edit Check Specification development