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.

? Associate Manager will assist others in the department with the responsibilities listed below.
? Manager will assist with many of the responsibilities and complete others with oversight.

Coordination of information posted on websites such as ClinicalTrials.gov, EudraCT, and others
Prepares scientific content of clinical trial results to be posted based on information contained in the protocol, Clinical Study Report, and Tables and Listings
• Reviews publically disclosed information such as medical publications or press releases to ensure consistency of information posted.
• Manages initial clinical trial registrations including data entry
• Serves as a point of contact for the Quality Assurance Reviewers from ClinicalTrials.gov as well as outside inquiries related to Clinical Trial Disclosure
• Updates websites with links to citations of publications related to registered clinical trials as needed
Multi-departmental resource for Clinical Trial Disclosure and Data Sharing information
• Coordinates with Clinical Operations, Clinical, Biostatistics and others to plan and complete required tasks
• Works with local country affiliates to ensure harmonization in process and consistency of information disclosed
• Communicates relevant timelines to appropriate departments
• Serves as a Quality Control reviewer of results data entered by others
• Serves as a resource within the organization about clinical trial disclosure and data sharing processes and policies
Coordination of Clinical Trial Disclosure and Data Sharing activities
• Tracks active clinical trials and records
• Monitors global shared in-box, prepares responses, and tracks requests
• Produces reports on activity, compliance, and/or other metrics.
• Using both manual and automated reporting tools, gathers and maintains information from multiple data sources; creates and distributes status reports summarizing the forecasted and actual activity
• Updates the study registration template to ensure compliance with changing global requirements
• Contributes to Working Procedures (WPs), Standard Operating Procedures (SOPs) and training material development
• Maintains regulatory intelligence and industry trends to assess and strategize business activities impacted by new or modified requirements
• Participates in process improvement initiatives
• Supports system implementation including but not limited to user acceptance testing

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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Qualifications
Scientific background including a Bachelor’s degree; Clinical Trial Disclosure experience preferred
Associate Manager: Minimum of 2 years clinical study management experience preferred
Manager: Minimum of 3 years clinical study management with multi-national experience required

Skills/Knowledge Required:
? Ability to critically analyze and interpret scientific content
? Good knowledge of statistical methodology in clinical studies and publication results
? Fluent in written and spoken English with strong interpersonal and communication skills
? Ability to work in a team environment and across all levels of the organization
? Good sense of organization and prioritization
? Demonstrated leadership ability
? Must be flexible and adaptable to changing project priorities and work assignments
? Knowledge of ICH and GCP guidelines

Could be based in any Celgene office.

Req ID: 14001512
Primary Location: United States-New Jersey-Basking Ridge
Job: Medical Affairs
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Manager
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 5 % of the Time
Job Posting: 2014-05-23 00:00:00.0