RTSM/eCOA Manager

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

📋 Description

• Oversee daily scientific operations, providing support to your team to achieve high-quality results.

• Assist in the design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems to fulfill protocol and study needs.

• Collaborate with Clinical Operations and study groups to comprehend RTSM/IRT/eCOA requirements, ensuring alignment on scope, timelines, and deliverables.

• Create and manage User Requirement Specifications (URS) and system design documentation.

• Guarantee the completion, review, and filing of validation and testing documents in line with quality standards.

• Offer ongoing RTSM/IRT subject matter expertise to cross-functional study teams throughout the study lifecycle.

• Identify, investigate, and resolve system defects and issues in conjunction with Quality, Clinical Operations, and vendors regarding deviations.

• Manage change control and urgent system modifications.

• Act as the main operational liaison between study teams, RTSM vendors, and internal functional teams.

• Ensure RTSM systems and documentation adhere to SOPs and relevant regulations.

• Supervise quality reviews and the approval of validation documentation.

• Handle RTSM user access requests, modifications, and removals, including overseeing periodic access reviews and audit preparedness.

• Ensure compliance with SOPs, regulatory requirements, and system security protocols.

• Assist in the development and implementation of standardized RTSM processes.

• Document comprehensive RTSM workflows and related guidance.

• Identify process deficiencies and promote continuous improvement in line with SOPs and regulations.

• Ensure RTSM processes facilitate inspection readiness and consistent execution.

• Develop role-specific RTSM training curricula and materials.

• Ensure training aligns with procedures, system functionalities, and regulatory requirements.

⛳️ Requirements

• Bachelor's degree required (BA/BS).

• At least 5 years of operational experience in clinical trials within a pharmaceutical company and/or CRO.

• Strong understanding of the clinical trial process, with extensive expertise in RTSM/IRT (IVRS/IWRS) and eCOA systems.

• Comprehensive experience managing RTSM system builds and updates from start to finish.

• Proven experience in leading User Acceptance Testing (UAT) and validation activities.

• Practical experience working with RTSM/IRT/eCOA vendors; vendor management experience is essential.

• Project management experience in handling complex, matrixed studies or programs.

• Familiarity with testing and issue-tracking tools.

• Ability to independently identify problems, analyze root causes, and implement solutions in a complex environment.

• Strong communication, negotiation, and stakeholder management skills.

• Demonstrated leadership, organizational, and prioritization abilities.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.