Clinical Project Manager, Head of CRO
Clinical Project Manager |Head of CRO
As a true people manager, Rachel is able to have various disciplines work together, both internally and externally, in order to successfully conduct studies. While working for medical device companies, she has been involved from product development, determine clinical strategy, study set-up until market release of the product. Support and training were provided to the development of the medical device production process and setting up their clinical department, quality systems and SOPs. Due to the variety of roles, Rachel is familiar to work at the office as well as in the field. This enables her to understand and respond to the practical approach of conducting studies for all parties involved. Areas of expertise are cardiology, pulmonology, urology, gastroenterology, orthopedics, pediatrics, CNS, dental, and software.
Rachel has over 20 years of experience in the clinical field. She has worked for several medical device and pharmaceutical companies all over the world in different phases, roles and areas
The key expertise areas of Rachel
- Experienced manager with expertise in human relations and project management.
- High performance on judgement, strategic thinking, relationship building, effective communication and planning.
- Experience in reorganization of clinical department.
- Provide clinical support (risk and quality management) during product development
- Coordinate the successful simultaneous development of several projects.
- Managing and training of clinical teams worldwide
- Knowledge of GCP/ICH, ISO14155 and regulatory compliance guidelines for clinical trials.
- Development of clinical study documentation and protocols
- Ensures objectives are accomplished in accordance with outlined priorities, planning and budget.
- Negotiated contracts that ensured quality.
- Develop collaborative relationships with KOL and study teams at site.
- Provide GCP, ISO14155 training
- Organizing and hosting Investigator Meetings
- Site management
- Over 10 years experience in CRA and CPM roles
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