Job Description
Join NovoPharm Solutions at the forefront of pharmaceutical innovation! We're seeking a dynamic Senior Clinical Research Associate to lead pivotal trials for next-generation therapeutics. In this critical role, you'll ensure regulatory compliance while mentoring cross-functional teams to accelerate drug development timelines. Our Cambridge headquarters offers state-of-the-art labs and collaborative spaces where your expertise will directly impact patient outcomes.
Responsibilities
- Design and execute complex clinical trial protocols adhering to ICH-GCP guidelines
- Monitor investigational sites to ensure protocol compliance and data integrity
- Lead cross-functional teams including biostatisticians and medical writers
- Develop comprehensive risk assessment and mitigation strategies
- Oversee regulatory submissions to FDA and international health authorities
- Mentor junior CRAs and conduct site investigator training
- Analyze safety data and prepare regulatory documentation
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field
- 5+ years clinical research experience in pharma/biotech
- Certified CRA (ACRP or SoCRA) required
- Thorough knowledge of FDA 21 CFR Part 312 and ICH-GCP
- Proven expertise in oncology or rare disease trials
- Advanced proficiency in clinical trial management systems (e.g., Medidata Rave)
- Exceptional problem-solving and stakeholder management skills
- Ability to travel 30% internationally