Senior / Principal Clinical Data Manager

Atlas Search; United States; On-site; USD 110,000 - 140,000; Full time

Job summary

Atlas Search is seeking a Senior / Principal Clinical Data Manager to lead data management tasks and ensure timely, high-quality deliverables for clinical studies.

You will manage design specifications, UAT plans, and data transfer docs while reviewing data and resolving queries across diverse data sources and vendors.

Qualifications

• Bachelor or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
• 3–5+ years of Pharma/CRO industry experience with at least 1–3 years of data management experience.
• Proficient knowledge of Medidata RAVE, Oracle InForm and/or IBM Clinical Development.

Responsibilities

• Act as the primary contact for data management timelines and deliverables; first line for technical or procedural issues.
• Perform hands-on data management tasks including design specs, UAT plans, and data transfer specs; oversee tasks for quality.
• Review data, issue and resolve queries from multiple data sources; assist sponsor, CROs, and sites as needed.
• Perform third party non-CRF data management activities.
• Plan and manage data processing and activities to meet sponsor requirements on time.

Skills

Data management

UAT

Query resolution

Communication skills

Team coordination

Education

Bachelor's or Master’s degree in health/pharma sciences or related fields

Tools

Medidata RAVE

Oracle InForm

IBM Clinical Development

Job description

We are currently partnered with a fast-growing pharma services company that is seeking a Senior / Principal Clinical Data Manager to join their team. This is a great opportunity to join a team that has always embraced new technologies and partnerships to accelerate product development and generate the clinical evidence to demonstrate real-world value.

Responsibilities:

• Act as the primary contact person for communication and discussion of topics related to data management timelines and deliverables; requests for out-of-scope tasks; and first line contact for technical or procedural issues.
• Perform hands-on data management tasks including, but not limited to, writing database design specifications, test plans for user acceptable testing (UAT), and data transfer specifications. When these tasks are assigned to Data Management support team members, the Principal Clinical Data Manager is responsible for review or to provide data management oversight and approvals for the task performed to ensure quality deliverable, including review of UAT plans to ensure accuracy and consistency among projects. Facilitate and participate in UAT, as necessary.
• Review data, issue queries, and resolve queries from various data sources (e.g., medical coding, medical history, adverse events, procedures and medicinal products, and external data). Assist other Clinical Research Organizations, Sponsor, or Investigative Sites with resolving queries.
• Perform third party non-Case Report Form data management activities.
• Plan, manage, and perform data processing and data management activities for assigned projects to ensure tasks are performed in a timely manner and in compliance with trial Sponsors’ requirements.

Requirements:

• A Bachelor or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
• Minimum 3-5+ years of experience of Pharma/CRO industry experience with at least 1-3 years of data management experience
• Proficient knowledge of Medidata RAVE, Oracle InForm and/or IBM Clinical Development