Job Description

Senior Clinical Data Manager

The Senior Clinical Data Manager (Sr. CDM) is responsible for data management activities across multiple studies. The Sr. CDM will report to the Manager, Clinical Data Management and will work closely with a cross-functional team in a fast-paced environment.

The Sr. CDM is responsible for leading the end-to-end data management activities and associated deliverables for clinical trials including study set-up, conduct and close-out, standards development and GCP compliance.

Responsibilities:

This is a direct, hands-on role and the main requirement is to perform, as well as manage, all day-to-day data management activities. Other responsibilities include, but are not limited to:

• Create, review and approve all data management study-related documents, which may include, but not limited to: eCRF/Database specifications, Edit Check specifications, Data Management Plan (DMP), UAT Plan Data Review Plan (DRP), CRF Completion guidelines, Coding Convention guidelines and other documentation as required.
• Perform and manage all data cleaning activities including processing queries, performing ongoing data review, and orchestrating scheduled cross-functional data review/reconciliation, identifying issues, data trends and tracking them through resolution.
• Perform and manage all database build activities, database validation and review and execution of User Acceptance Testing (UAT).
• Represent Data Management in internal study team, client and CRO meetings.
• Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities.
• Work with outside vendors (such as safety laboratories, cardiac laboratories) to develop data transfer documents and perform regular data reconciliation with the clinical database.
• Assist DM oversight role/manager in monitoring timelines and managing resources to meet timelines.
• Identify inconsistencies and inefficiencies in data management processes and recommend solutions.
• Have a thorough understanding of the study billing guide, manage expectations with the support Clinical Data Manager(s) on the assigned tasks, available hours, and keep the billing guide current.
• Enter and verify the time spent on project and non-project work on InClin's time tracking tool regularly (daily time entries preferred, weekly at the minimum).
• Direct team members in daily activities including training and supervising study support staff.

Knowledge & Skill Requirements:

• 9+ years data management experience and B.S./B.A. in a science or technical discipline degree.

• Previous CRO experience is strongly recommended.

• Proficient in MS Excel.

• Ability to program in SQL or SAS desirable, but not required.

• Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes. Medidata Rave EDC, Medrio eClinical and Clario EDC experience are preferred, but not required.

• Excellent oral and written communication skills.

• Ability to work in a collaborative and multi-disciplinary environment.

• Attention to detail, ability to prioritize and manage multiple projects with competing and aggressive timelines.

• Availability to travel for clinical team meetings and/or Investigator Meetings if needed.

• Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.

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