Clinical Program Manager – Diagnostics

We are seeking a skilled and experienced Clinical Program Manager (CPM) to lead and manage clinical programs supporting innovative, best-in-class diagnostic technologies. The CPM is responsible for the strategic planning and execution of clinical research studies, ensuring on-time delivery, budget adherence, and compliance with regulatory and quality standards.

Key Responsibilities:

• Lead the strategy, planning, and implementation of clinical research studies from concept through final reporting.

• Oversee cross-functional teams to ensure execution of trials in accordance with GCP, internal procedures, and applicable regulatory requirements.

• Develop and maintain clinical program timelines aligned with broader clinical and regulatory strategies.

• Communicate study status, timelines, budgets, and deliverables to leadership and internal stakeholders.

• Anticipate, identify, and resolve clinical trial risks or issues; lead contingency planning as needed.

• Ensure delivery of high-quality data and documentation in support of regulatory submissions.

• Collaborate with quality and regulatory teams on audits and inquiries.

• Mentor junior team members and support departmental development and continuous improvement.

• Engage with key opinion leaders and subject matter experts to enhance clinical strategy and trial execution.

Qualifications:

• Bachelor’s degree in Life Sciences or related field (Master’s degree preferred).

• Minimum of 4–6 years of industry experience in clinical program/project management.

• Experience in diagnostics (IVD), biotechnology, medical devices, or pharmaceuticals.

• Strong understanding of clinical trial design, execution, data analysis, and regulatory processes.

• Proven track record managing cross-functional teams and multiple priorities effectively.

• Deep knowledge of GCP, clinical affairs operations, and clinical trial regulations.

Skills:

• Strong leadership, interpersonal, and communication skills.

• Excellent project management and organizational abilities.

• Ability to adapt to changing priorities and manage multiple projects simultaneously.

• Analytical mindset with attention to detail and strong problem-solving skills.