Job ID: 13769
Location: Warren Township, NJ - 33
Full/Part Time: Full-Time
Category: Clinical - CCT
Department: Clinical Research & Dev - 3604
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
Summary/Scope: Responsible for all aspects of the planning and execution of a clinical trial or trials
Responsibilities will include, but are not limited to, the following:
1. Assist the Clinical Research Physician to interface with project 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, etc.
4. Participate in Development Planning for assigned compounds.
5. Leads cross functional study team to deliver clinical research studies on time, within budget and with good quality (select and evaluate study sites, select and evaluate vendors, preparation of study documentation, initiation, monitoring, following up and closing out of sites, maintaining databases).
6. Interface with, or supervise, Clinical Trial Assistants (Clinical Operations Coordinators) as well as external contractors who will assist with study operations.
7. Protocol preparation (writing, reviewing and cross-functional facilitation as appropriate).
8. Assist with review of ongoing summary data including: safety, primary efficacy variables, laboratory data.
9. Clinical study report preparation.
10. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.
1. Minimum 1-2 yrs. experience in medical or technical writing
2. Extensive medical/scientific and clinical research knowledge
3. Knowledge of Medical Terminology
4. Knowledge of protocol design, implementation and proficient at data interpretation
5. Experience in protocol development, study report preparation, Investigator Brochure preparation, IND safety updates
6. Leadership skills (get it done) / negotiation skills
7. Mentoring / coaching
8. Time management - ability to effectively multi-task and prioritize
9. Knowledge of GCP and ICH Guidelines / FDA regulations and EU directive
10. Experience in presenting at Investigator Meetings
11. Detail-oriented, well-organized
12. Limited travel required
13. Ability to assimilate technical information quickly
14. Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus
15. Demonstrated ability to work as part of a team
16. High level of interpersonal and communication skills (written and verbal)
17. Study Tools including electronic system skills – CTMS / EDC
18. Knowledge of drug development process (North America and global)
Key (PDI) Competencies:
2. Manages execution
3. Fosters open communication
4. Fosters team work
5. Drive for results
6. Commitment to quality
7. Demonstrates adaptability
8. Leverages networks
9. Uses technical functional implications
10. Recognizes global implications
11. Acts with integrity
12. Thinks strategically
13. Develops oneself
14. Uses financial and quantitative data
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
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.
Celgene - 17 months ago
Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.