Job Description

Job Description

Job Description

Job Title: Clinical Data Manager

Job Status: FT

Location: Lotus Clinical Research 100% Remote

Who we are:

About this role:

The Clinical Data Manager is responsible for oversight and conduct of data management activities in an efficient manner and in accordance with all SOPs and regulations. Responsibilities include all data management activities, customer relationship management, development and implementation of the data correction process, discrepancy resolution, data control activities, and data validation. This is a FT role.

Responsibilities:

Proactively and independently manage data management activities on assigned studies, including but not limited to setting and management of timelines, milestone deliverables from study start up through close out in accordance with ICH/GCP, SOPs, and regulations.

• Review protocol and provide comments and or suggested changes.
• Work with the project team to draft & finalize CRF specification, edit check specifications, and all data management specific study documents.
• Implementation of all data cleaning processes, discrepancy resolution, data transfer/control activities, and validation.
• Lead and/or coordinate the user acceptance testing through the build phase of the EDC platform to ensure completeness and correctness.
• Develop and implement the Data Management Plan which outlines the end-to-end handling of the data correction process, discrepancy resolution, data control activities, and data validation.
• Proactively manage project though supervision and quality control of assigned team members’ and Clinical Data Coordinators’ work.
• Proactively participate in appropriate sponsor/project team meetings.
• Communicates with cross functional groups throughout the project lifecycle. Monitors project scope and notify the Project Manager of any out-of-scope activities prior to conducting any such activities.
• Performs other duties as assigned.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Ensure documentation and management of clinical study data is in accordance with regulations. Proactively coordinate and perform start-up, conduct, and closeout activities as detailed within SOPs. Proactively manages timelines and projections.

Education and/or Experience:

• BS/BA in health science, life science, information technology, or nursing is preferred but not required.
• Minimum of 3 years of related clinical research experience required
• Minimum of 3 years of DM experience preferred
• Veeva EDC and Medidata RAVE experience preferred
• Fluent in English with excellent verbal and written communication skills. Working knowledge of EDC systems.
• Knowledge of the drug development process.
• Thorough knowledge of ICH guidelines, GCP, and the clinical trial process.
• Experience using electronic clinical research platforms and processes.
• Excellent interpersonal skills.
• Strong computer skills, including Microsoft Office. Exceptional attention to detail.
• Ability to interact effectively within and across team environments.
• Excellent organizational skills. Study documentation production and maintenance, data processing, data review.

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