Senior Manager, Clinical Data Management

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee data management functions for clinical studies or programs.

• Act as the primary Clinical Data Management lead for several clinical trials.

• Ensure the quality and integrity of data for complex and pivotal clinical studies.

• Supervise tasks detailed in the Data Management Plan.

• Create strategies for data acquisition.

• Confirm that supporting systems are validated and fulfill the study requirements.

• Manage outsourced Clinical Data Management vendors.

• Engage in vendor selection and oversight.

• Assess vendor invoices as necessary.

• Collaborate with cross-functional teams to achieve data deliverables.

• Improve Clinical Data Management procedures and enhance cross-functional teamwork.

• Assist with departmental initiatives.

• Lead inspection activities related to Clinical Data Management.

• Address and resolve inspection findings.

• Ensure that Clinical Data Management documentation is thorough and filed in the Trial Master File.

• Carry out additional duties and responsibilities as assigned.

⛳️ Requirements

• Bachelor’s or master’s degree.

• More than 8 years of experience in Clinical Data Management.

• Strong communication, organizational, and project management abilities.

• Familiarity with FDA/CFR and ICH/GCP guidelines.

• Knowledge of CDISC and CDASH standards.

• Experience in leading complex or pivotal clinical trials is preferred.

• Preferred experience in vendor oversight.

• Experience supporting inspections and audits is preferred.

🏝️ Benefits

• Annual performance bonus.

• Long-term incentive plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan with company matching.

• Generous parental leave.

• Family planning benefits.

• Opportunities for personal and professional development.

• Additional incentive compensation plans (if applicable).