Celgene Sr. Principal Programmer, Data Capture and Review Librarian in Summit, New Jersey
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:
Manages Libraries and associated object used for study configuration which have been approved through governance.
Facilitates discussion for identification of objects which will be used for study configuration
Supports Disease Indication scientist from various therapeutic functions to proactively create new commonly used CRF’s which could be consumed by study
Maintains various EDC libraries with disease indication scientist
Maintains consistency between Rave Library and MDR and/or other standards (if applicable)
Creates and Maintains following objects in Safety Gateway Module
Standard mappings which are consumed for Safety Gateway module
Act as liaison for any updates required to standard mappings
Creates and facilitates activities required for consistent consumption of Medical Coder tool
SME for library consumptions in Rave, Coder, Safety Gateway and other modules which have functionality to standardize content used for study consumption
Conducts training on Library and management across different Medidata modules
Maintains consistency between Library and other sources of information stored in multiple systems (i.e., MDR)
Liaison with the standard governance organization to maintain alignment with the business and proactively look for opportunities to build efficiencies.
Interact with FSP to confirm understanding of Celgene Library for consistent study consumption
Acts as Subject Matter Expert (SME) for Global Library, Medical Coder and other Medidata module configuration at study level
Works with cross functional SME community to address issues/questions within Celgene
Conducts training on Library consumption and management across different Rave modules
Participates in development of new training as needed for supporting user community
Act as owner to address any training or process gaps identified by Celgene user community
Manages risk mitigation, issue resolution and escalation related to Rave Global Library
Develops, Monitors and tracks metrics for standards consumption and identifies process to continuously increase reuse rate and collaborate with other functions roles like Data Manager, Project Standards Manager, Global Standards Manager and others.
Represents Celgene in Medidata user forums and co-ordinates Celgene representations as needed
Cross functional collaboration:
Lead the development of department or cross-functional SOPs, Working Practices and best practices for the department related to the Library Capability
Support cross functional initiatives and ensure that DCR change management is implemented for Library related activities
Provide guidance for resolving Library capability concerns raised
Work with cross functional team to approve and execute process updates to Library
Liaison with the standard governance organization roles like Project Standards Manager and Global Standards Manager to maintain alignment with the business and proactively look for opportunities to build efficiencies.
Interact with Functional Service provider (FSP) at a portfolio level to confirm understanding of Celgene Library for study consumption
Participate in meetings with FSP at a portfolio level as needed
Work Internally and externally with different teams to implement DCR capability and process improvements
BA/BS in a relevant scientific discipline
5-7 years Pharmaceutical/CRO experience as a clinical programmer supporting clinical trials for regulatory submissions.
Expert knowledge or certified in the Medidata product Rave is required. Global Library, Safety Gateway, Coder and Patient Cloud knowledge is highly desirable.
Demonstrated knowledge in programming environments, systems and networking as it relates to the pharmaceutical industry.
Have in-depth understanding of clinical data structure as well as relational databases
Demonstrated skills in using software tools and applications, e.g., MS office, XML, HTML, etc.
Have an understanding of regulatory requirements pertaining to technology, systems, and standards.
Ability to research new technologies and ensure alignment with regulatory agencies and industry standards
Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
Demonstrated ability to work in a team environment with clinical team members.
Excellent planning and project management skills
Good interpersonal, communication, writing and organizational skills
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.
Sr. Principal Programmer, Data Capture and Review Librarian
Location: Summit, NJ, US
Job ID: 17001327