Job Description
Are you a visionary leader ready to drive groundbreaking advancements in the healthcare sector?
MedTech Innovations Inc. is looking for a Senior Clinical Project Manager to spearhead the clinical development lifecycle of our next-generation medical devices. In this pivotal role, you will bridge the gap between complex scientific research and market-ready products, ensuring compliance, efficiency, and patient safety at every step.
MedTech Innovations Inc. is looking for a Senior Clinical Project Manager to spearhead the clinical development lifecycle of our next-generation medical devices. In this pivotal role, you will bridge the gap between complex scientific research and market-ready products, ensuring compliance, efficiency, and patient safety at every step.
Responsibilities
- Lead the end-to-end management of clinical trials, ensuring strict adherence to timelines and budgets.
- Collaborate with cross-functional teams including regulatory affairs, biostatistics, and engineering to align project goals.
- Ensure full compliance with Good Clinical Practice (GCP) and FDA regulations across all study phases.
- Conduct comprehensive risk assessments and implement proactive mitigation strategies.
- Oversee data integrity, monitor KPIs, and prepare comprehensive study reports for stakeholders.
- Act as the primary point of contact for internal teams and external CROs, vendors, and investigators.
Qualifications
- Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Minimum of 5+ years of experience in clinical project management within the biotechnology or medical device industry.
- Proven track record of successfully managing Phase I-III clinical trials from initiation to close-out.
- Project Management Professional (PMP) or Certified Clinical Research Professional (CCRP) certification is highly preferred.
- Expert knowledge of FDA, EMA, and ICH guidelines and regulatory submission processes.
- Exceptional analytical, organizational, and communication skills with a focus on detail.