ProClinical has a brilliant opportunity for a Clinical Project Scientist to be based in Bridgewater, New Jersey. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors. The Clinical Project Scientist position will be filled by a high performing individual who demonstrates a strong scientific background and a track record for accomplishment in a team setting.
- Perform medical monitoring activities
- Perform data/safety reviews
- Support the interpretation and reporting of results including preparation for FDA submissions for ongoing clinical trials
- Review safety and efficacy outcome events and SAEs on routine basis
- Query outcome events and SAEs, ensure resolution, and track to completion
- Track outcome events and SAEs
- Oversee and conduct clinical review of subject narratives to fulfil IDMC and CSR requirements
- Write and review safety sections of CSRs
Skills and Requirements:
- Bachelor's degree required; Advanced degree (MS, PhD or PharmD) preferred
- 5+ years of clinical research experience strongly preferred
- 3+ years of high level, hands-on clinical research and development experience required
- Experience reviewing and understanding medical charts, case report forms, and SAEs required
- Phase II-III clinical research experience preferred
- CRA monitoring experience preferred
- Safety monitoring experience within the pharmaceutical industry preferred
- Experience in Internal Medicine or Cardiovascular product development preferred
- Strong interpersonal and communication skills required
- Must demonstrate ability to operate in a matrix environment
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mary Jacobs on +1 267 477 4800 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.