Senior Manager

We are looking for a highly skilled Project Manager with a PMP certification to lead and manage projects centered on clinical trial data management. The successful candidate will have hands-on experience with clinical trial technology tools such as CTMS, EDC, and ePRO. A strong background in clinical research is essential, along with a deep understanding of regulatory standards including ICH-GCP, GxP, and FDA Part 11 compliance. This role demands a detail-oriented professional who can ensure the highest standards of clinical trial compliance and data integrity while effectively coordinating cross-functional teams.

Key Responsibilities
- Manage and oversee clinical trial data management projects, ensuring they are delivered on time and meet quality expectations.
- Coordinate the implementation and utilization of clinical trial technology tools including CTMS (Clinical Trial Management System), EDC (Electronic Data Capture), and ePRO (electronic Patient-Reported Outcomes).
- Collaborate closely with cross-functional teams to ensure strict adherence to clinical research protocols and regulatory guidelines.
- Monitor project progress, proactively identify risks, and implement mitigation strategies to maintain compliance and quality standards.
- Ensure that all project activities comply with ICH-GCP, GxP, and FDA Part 11 regulations.
- Facilitate effective communication among stakeholders including clinical operations, data management, and regulatory affairs teams.
- Maintain comprehensive project documentation and reporting to support audits and regulatory inspections.

Required Qualifications
- PMP (Project Management Professional) certification is mandatory.
- Proven experience managing projects specifically involving clinical trial data management.
- Practical experience with clinical trial technology tools such as CTMS, EDC, and ePRO.
- Strong knowledge of clinical research processes and regulatory requirements, including ICH-GCP, GxP, and Part 11 compliance.
- Excellent organizational and communication skills to manage project timelines and stakeholder expectations effectively.

Preferred Qualifications and Benefits
Candidates with additional certifications or experience in clinical operations or regulatory affairs will be viewed favorably. This position offers the opportunity to work in a dynamic environment focused on advancing clinical research through innovative technology solutions. It is ideal for professionals who thrive in regulated environments and are committed to maintaining the highest standards of compliance and data integrity in clinical trials.