Clinical Research Scientist

7 days left

Employer
Location
Summit, NJ US
Salary
Competitive Salary
Posted
Sep 09, 2016
Closes
Oct 07, 2016
Ref
16001662
Result Type
Jobs
Position Type
Permanent
Hours
Full Time

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

 

Responsibilities will include, but are not limited to, the following:

  • Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
  • Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
  • Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
  • Clinical study report preparation
  • Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
  • Participate in Development Planning for assigned compounds.
  • Oversee and challenges the adequacy of planning for study implementation
  • In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
  • Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
  • Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
  • Collaborates and supports operational activities as need be.
  • Assist in establishing project budgets
  • Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
  • Participate and present at investigator meetings
  • Participate in adhoc meetings (e.g. marketing)
  • Assist in document template design and SOP writing
  • Participate on various corporate committees
  • Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required
  • Lead team meetings as required
  • Qualifications

    Prerequisites: 

    Advanced Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), minimum 7 years experience in clinical research development or equivalent.

     

    Skills/Knowledge Required:

    • Minimum 2 years experience in medical or technical writing
    • Clinical monitoring experience preferred
    • Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
    • Extensive medical/scientific and clinical research knowledge
    • Knowledge of Medical Terminology
    • Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
    • Proficient at data interpretation
    • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
    • Experience in all aspects of the drug development process
    • Knowledge of GCP and ICH Guidelines
    • Experience in presenting at Investigator Meetings
    • Detail-oriented, well-organized
    • Limited travel required
    • Ability to assimilate technical and scientific information quickly
    • Clinical project management skills
    • Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus
    • Demonstrated ability to work as part of a team
    • High level of interpersonal and communication skills (written and verbal)

     

    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.

     

     

     

    *LI-TS1