Clinical Research Scientist / Senior CRS Job
Location: Summit New Jersey
Description: Celgene is at the momment seeking for Clinical Research Scientist / Senior CRS Job right now, this position will be placed in New Jersey. More complete informations about this position opportunity kindly read the description below. Troubleshooting Tips
Job Title:
Job ID: 13929
Location: Summit, NJ
Offsite Territory:
! Full/Part Time: Full-Time
Regular/Temporary: Regular
Category: Clinical
Department: Hematology/Oncology - 3606
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), 5-10 years experience in clinical research development or equivalent
Responsibilities will include, but are not limited to, the following:
1. Assist the Clinical Research Physician to ! interface with study/clinical team members including: Clinical! Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
3. Review literature and prepare summary documents for inclusion in IB, protocols, Briefing documents, etc.
4. Participate in Development Planning for assigned compounds.
5. Protocol preparation (writing, reviewing and cross-functional facilitation as appropriate).
6. Assist with review of ongoing summary data including: safety, primary efficacy variables, laboratory data.
7. Clinical study report preparation.
8. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.
Skills/Knowledge Required:
- Minimum 2-5 yrs. experience in medical or technical writing
- Exte! nsive medical/scientific and clinical research knowledge
- Knowledge of Clinical Date Review
- Knowledge of protocol design, implementation and proficient at data interpretation
- Experience in protocol development, study report preparation, Investigator Brochure preparation, IND safety updates
- Experience in all aspects of the drug development process (device & tissue experience an added benefit)
- Knowledge of GCP and ICH Guidelines
- Experience in presenting at Investigator Meetings
- Detail-oriented, well-organized
- 35% travel required
- Ability to assimilate technical information quickly
- Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project
- Demonstrated ability to work as part of a team
- High level of interpersonal and communication skills (written and verbal)
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
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If you were e! ligible to this position, please email us your resume, with salary requirements and a resume to Celgene.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Mon, 05 Aug 2013 00:03:19 GMT