Sr. Clinical Data Manager

Meet Life Sciences; United States; On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Data Manager to provide expertise in clinical data for drug and biologics development. This role involves leading data management activities, ensuring data integrity, and collaborating with cross-functional teams. The ideal candidate will have a strong background in clinical research, particularly in Oncology, and will be responsible for managing vendor performance and mentoring team members. If you are detail-oriented, organized, and thrive in a fast-paced environment, this is an exciting opportunity to make a significant impact in the field of life sciences.

Qualifications

• 4+ years in Clinical Data Management with Pharma, Biotech, or CRO experience.
• Strong knowledge of ICH, FDA, GCP regulations, and industry standards.

Responsibilities

• Lead Data Management activities for both outsourced and insourced projects.
• Ensure data integrity and manage Data Transfer Agreements and workflows.
• Collaborate with cross-functional teams and maintain regulatory readiness.

Skills

Clinical Data Management

Communication Skills

Data Integrity Management

EDC Systems (Medidata preferred)

Regulatory Standards (ICH, GCP)

Vendor Management

Risk Assessment

Education

Bachelor’s Degree in relevant field

Tools

EDC Systems

Job description

The Senior Clinical Data Manager provides clinical data expertise for both outsourced and insourced projects, supporting drug and biologics development. This role requires advanced knowledge of the clinical research lifecycle, data management processes, and regulatory standards (e.g., ICH, GCP). The Senior Clinical Data Manager will manage Data Management activities, oversee vendor performance, and may mentor team members.

Responsibilities:

• Lead or support Data Management activities for both outsourced and insourced projects.
• Act as Lead or Support Data Manager on insourced studies and Oversight Lead for outsourced studies.
• Collaborate with cross-functional teams, providing expertise and ensuring proactive communication, risk assessment, and mitigation strategies.
• Manage start-up activities, including protocol development, EDC documentation, Data Management Plans, and cross-functional collaboration.
• Ensure data integrity in clinical and vendor databases, including managing Data Transfer Agreements and data transfer workflows.
• Participate in data cleaning, third-party data reconciliation, query management, and metrics reporting.
• Review and contribute to study documents (e.g., Protocols, Safety Plans, Statistical Plans, etc.).
• Maintain documentation to ensure regulatory inspection readiness.
• Develop, review, and revise SOPs and templates.

Requirements:

• Bachelor’s Degree or equivalent experience with 4+ years in Clinical Data Management (Pharma, Biotech, CRO, or Academic experience; Oncology preferred).
• Phase III experience required.
• Strong communication skills, with the ability to explain complex Data Management and EDC concepts to cross-functional teams.
• Highly organized, detail-oriented, and self-motivated with the ability to manage multiple tasks in a fast-paced environment.
• Experience with EDC systems (Medidata preferred) and data management best practices.
• Strong knowledge of ICH, FDA, GCP regulations, and industry standards (SDTM, CDISC, CDASH).
• Proven vendor management and data transfer workflow experience.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Other