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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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Associate Director

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:

- Bachelor's degree in computer science, business administration, engineering or a related discipline with an information technology focus; highly desirable to have M.B.A. degree or equivalent, PMP or PgM certified, extensive related project management experience
- Eight to twelve years of progressive broad-based project or program management experience;
- Five to seven years of demonstrated management/supervisory experience in systems development or IT Operations
- Five or more years working in the pharmaceutical or bio-technology sector. Familiarity with systems and processes related to Clinical Operations, Outsourcing and Contract Management, Data Management, Clinical Trials Disclosure, Data Standards, and Clinical Programming. Expertise with systems and processes related to interfacing Clinical systems with Drug Safety, Statistics, and Regulatory.

Summary:

Program management is the coordinated planning, management and execution of multiple related projects that are directed toward the same strategic, business or organizational objectives.

Program management activities revolve around managing issues at the intersection of multiple project-related activities. This role is tasked with determining how the organization handles and "manages the management" of projects. While this includes project management methodology and practice standards, it expands to include prioritization and governance of projects as well as realizing and measuring the benefits that projects bring to the entire organization.

- Has overall responsibility for planning, directing and coordinating activities pertaining to technology and business-unit projects, at the highest level for multiple projects
- Ensures that project goals are accomplished and in line with business objectives
- Is responsible for governing the team that develops and carries out internal IT and Business Units projects

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

- Consult with management and review approved projects to determine goals, time frame, funding limitations, procedures for accomplishing project, staffing requirements and allotment of resources.
- Review and approve project plans, specifying goals, strategy, staffing, scheduling, risks, contingency plans, and allocation of available resources.
- Ensure adherence to technical scope and objectives of projects.
- Ensure adherence to scheduled project deliverables, milestones, and required tasks.
- Resolve conflicts in assigned duties, responsibilities, and scope of authority to project personnel.
- Direct and coordinate activities of project management personnel to ensure project progresses on schedule and within budget.
- Review status reports prepared by project personnel, and oversees the modification of schedules and plans as required.
- Prepare program status reports, and keep management, clients and others informed of program status and related issues.
- Confer with project personnel to provide technical advice and resolve problems.
- Coordinate and respond to requests for changes from original specifications.
- Monitor project results against plan.
- Review and approve technical and project documentation.
- Assume key overall responsibility for ensuring that project participants have easy access to information that is useful to them.
- Other responsibilities as assigned


Skills/Knowledge Required:

- Ability to create and maintain project schedules, budgets and forecasts, manage issues and risks, and execute against plans
- Capability to manage internal and external projects from inception to successful implementation
- Firm understanding of the software development/configuration process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary testing methodologies and deployment management
- Expertise in setting and managing customer expectations
- Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management
- Strong customer focus and ability to manage client expectations
- Ability to communicate needs and schedules to IT and clients, as well as ensure that plans are in place and standards are adhered to
- Solid project management skills with ability to multitask and manage multiple small to large projects in a cross-functional environment
- Demonstrated ability to lead and motivate staff to apply skills and techniques to solve dynamic problems
- Excellent oral and written communication skills, as well as ability to present and explain technical information in a way that establishes rapport, persuades others and gains understanding

- Regulations / Standards
- Computer Validation and 21 CFR Part 11
- ICH Guidelines, EMEA, FDA, UKSI, and EU Directive
- Strong Understanding of Good Clinical Practices (GCP) regulations
- Knowledge of global standards related to clinical study data management activities (CRF design, data standards (CDISC, SDTM, ADaM), database design, coding and coding dictionaries.
- Familiarity with industry standards TMF Reference Model.
- Current with industry best practices and participate in DIA, SCDM, Oracle user groups, etc.

- Trial Master File
- Clinical Investigator Portals and Electronic Trial Master Files (eTMF)
- Familiarity with NextDocs
- Integration of eTMF with CTMS
- Document Management and collaboration systems Livelink, Documentum, SharePoint.
- Integrated scanning solutions – Captiva

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.


Nearest Major Market: New Jersey
Job Segments: Biology, Biotech, Clinic, Clinical Research, Computer Science, Contract Manager, Data, Data Management, Database, Document Management, Engineer, Engineering, Healthcare, Hematology, Information Technology, Law, Legal, Management, Manager, MBA, Medical Research, Medical Technologist, Oncology, Oracle, Pharmaceutical, Program Manager, Project Manager, Science, Sharepoint, Technology, Testing

Other Job Information

Vacancy type:

Full Time

Contact Mode:

not provided

Fax:

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Contact Name:

not provided

Job Duration:

not provided

Phone:

1-908-673-9000

Email:

not provided

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