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Sr. Clinical Research Associate

Req #: 1701062
Location: San Diego, CA US
Job Category: Medical
Work Location: 3033 Science Park Road Suite 300 RCPTSD 92121
Organization: Receptos, Inc.
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- CA- San Diego- Science Park

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 and Duties:

  • Assists with establishing and maintaining study budget and timelines.
  • Serves as the primary project lead for communication and coordination of third-party vendors, escalating issues to Senior Management as appropriate.
  • Coordinates the execution of outsourced Global Phase 2 and 3 Clinical trials.
  • Coordinates and supports clinical team meetings and Vendor Team meetings.
  • Under the supervision of the Project Manager or Director, supports the management and oversight of CROs and other clinical study related vendors.
  • Assists with management of vendors working directly with Receptos. Under the supervision of the Project Manager or Director, manages project contracts, including finalization of initial task order and subsequent amendments, forecasting, assessment of work performed and appropriate site/vendor payments.
  • Directs study teams to identify and manage critical path activities such as selection of countries and sites, selection and management of vendors, development of risk management plan, CRF development, EDC system development, study portal setup, study monitoring, safety reporting, IRB/regulatory submissions and approvals, and study status reporting.
  • Apprises Project Manager and Director of all critical path activities and provide routine updates for all activities related to projects assigned.
  • Manages and oversees the performance of the study team to include third-party vendors and Regional CRAs/In-house CRAs.
  • Participates in the development, review and implementation of protocols, amendments, eCRFs, Guidelines, Monitoring Plans and Tools, IBs, Clinical Study Reports, abstracts and presentations, departmental SOP's and processes.
  • Supports the management of Investigational Product supply and distribution.
  • Manages the overall review of the clinical database and data listings to ensure that accurate data is delivered in a timely manner.
  • Supports the training of internal and external project team members (including CROs) on the protocols, Good Clinical Practice, and other study-related activities from study initiation throughout the duration of the project.
  • Contributes to the development and implementation of policies and procedures regarding study related activities.
  • Responsible for setting and meeting clinical goals and objectives.
  • Other responsibilities as assigned.

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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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