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Celgene Corporation

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 drugs for our patients. Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.There are more than 300 clinical trials at major medical c... Read More

Address      86 Morris Avenue Summit, NJ 07901
Website      www.celgene.com
Holding      No Holding Details

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Data Management

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.

Prerequisites:

- BA/BS in a relevant scientific discipline; minimum 12 years experience in data management roles, including at least 5 years of management experience in a pharmaceutical/CRO.
- Demonstrated management skills and experience leading a team
- Knowledge of Drug Development process
- Good communication skills; ability to work in a team environment
- Strong analytical skills
- Knowledge of FDA/ICH guidelines and industry standard practices regarding data management
- Knowledge about requirements of New Drug Application (NDA)/Market Authorization Application (MAA) submission to authorities
- Previous experience with CDM systems including EDC; sound understanding of database and programming concepts, database structure
- Previous experience at or oversight of outside Clinical Research vendors (CRO’s, Central Labs, Imaging vendors)

Resource planning/management experience

Summary:

- Manage and support a group of Clinical Data Managers while prioritizing and directing resources requirements across multiple projects in assigned Therapeutic areas, according to SOPs, guidelines and regulations. Also participate in budgeting and forecasting for CDOSS department resources.
- Direct responsibility for supervising Data Managers in the performance of their duties with overall project priorities and timelines
- Manage resources and staff workload for their assigned projects. Ensure studies are resourced appropriately
- Manage , mentor, and evaluate performance of Data Management staff, including setting-up goals and objectives, conducting performance evaluations, and providing staff with guidance on technical/project related issues, people development
- Ensure Data-Management staff adheres to SOP and working practices for their assigned projects
- Participate in developing, defining, maintaining, and enforcing Data-Management standards
- Ensure process and standards are being followed and initiate process improvement activities if necessary
- Ensure appropriate interactions occur with personnel from other groups, such as Biostatistics, Clinical Programming, Clinical Development, Quality Assurance
- Liaise with third party vendors, such as CRO’s, EDC in a project management capacity
- Maintain forecasting for Data-Management resources.
- Manage recruitment process in collaboration with Recruiters and Human Resources
- May participate in cross-functional process improvement initiatives
- Stay abreast of industry developments in the Clinical Data Management field and apply to appropriate systems or processes

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.

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

not provided

Contact Name:

not provided

Job Duration:

not provided

Phone:

1-908-673-9000

Email:

not provided

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