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.
The Senior Project Standards Manager within the Clinical Data Standards and Integration (CDSI) group will manage the activities associated with the consistent implementation of clinical data standaResponsibilities will include, but are not limited to:
- Operational Support for Implementation of Celgene Data Standards
•Independently develop and maintain project data standards, considering the needs of individual studies within the project, while following Celgene global data standards. Make decisions in conjunction with Global Standards Manager(s) regarding when project data standards can and should deviate from Celgene global data standards. Data standards will include, but not be limited to, the CDISC Study Data Tabulation Model (SDTM), Controlled Terminology, or other relevant, current industry standards models.
•Provide input into individual study deliverables with data standards components, including:
•CRF design, ensuring consistent CRF standards (including metadata) are used for all studies in a project
•CRF Completion Guidelines, to ensure consistency across studies within a project in how and when CRFs are completed
•Programmed edit checks, to ensure consistency across the studies within a project
•Data transfer specifications, to ensure consistency across the project in external data structure to facilitate mapping to the SDTM standard
•SDTM mapping specifications and SDTM annotated CRF, to ensure consistent SDTM mapping for studies within a project
•Work with standards management systems and software, such as Metadata Repository, OpenCDISC, and issues tracking systems.
•Act as a consulting resource for study teams regarding the validation of SDTM domains, which may include output from software tools such as OpenCDISC and Celgene custom validation programs.
•Communicate and reinforce content and interpretation of Celgene data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project.
•Act as the key point of contact for project specific standards implementation issues.
•Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology.
•Provide input into project and study timelines and vendor contractual agreements.
•Participate in project and study team meetings as needed, specifically in a supportive capacity.
•Coach CROs and vendors on Celgene data standards and related processes.
•Provide standards support to multi-project development programs, including early strategic assessments.
2. Standards Support for Submissions
•Provide leadership and guidance to Submission Team regarding overall project strategy related to data standards for regulatory filings, including how data are to be submitted, the format in which individual studies are to be submitted, and what version of the coding dictionaries are to be used.
•Work with the Submission Team to prepare regulatory correspondence regarding submission standards.
•Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer's Guide, XPT files).
•Act as a consulting resource for study teams regarding the validation of eCRT/define packages.
•Participate in submission team meetings.
3. Other Key Activities
•Provide project oversight and coaching to more junior personnel, or manage contract staff.
•Lead development of department or cross-functional processes and best practices, including CDSI SOPs, Working Procedures, and Guidance Documents.
•Lead or participate in strategic initiatives, special projects, and working groups.
•Participate as a member in Celgene's Clinical Data Standards Governance Organization (CDSGO).
BA/BS in a relevant health science or computer science discipline; minimum experience: 10 years as a programmer, data manager, or data standards manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience
•BA/BS in a relevant health science or computer science discipline; minimum experience: 10 years as a clinical programmer, data manager, or data standards manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience. Medical background is a plus.
•Strong working knowledge of the overall pharmaceutical development process.
•Strong working knowledge of SDTM and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
•Strong project management and negotiation skills.
•Ability to work effectively on an independent basis in a cross-functional team environment, across Celgene departments, and with external vendors.
•Computer skills: knowledge of data structures within clinical data management systems, especially electronic data capture systems; understanding of SAS, including ability to use SAS System Viewer and to create basic SAS queries. Experience in programming databases is a plus. Experience with a Metadata Repository or other related standards management system is preferred.
•Experience in CRF design, query resolution, and general data validation.
•Good communication skills, high ability to communicate standards related issues, options, and their impact to project teams and within department.
•Ability to work and lead effectively in a team environment with medical personnel, study managers, project managers, clinical monitors, data managers, programmers, and statisticians.
•Experience with regulatory submissions or working with submission teams.
•Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data.
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.