Working closely with the Global Clinical Data Standards (GCDS) Director of Delivery Management within the Global Data Management & Standards (GDMS) organization, the Global Data Standards Manager is responsible for the development, implementation, and oversight of the standards delivery framework and associated processes that drive end-to-end planning, delivery, and governance of GDMS standards components.
The Manager may also lead or serve as a member of various GCDS and cross-functional teams within GDMS.
The Global Data Standards Manager is responsible for the ongoing management and timely delivery of standards and governance related deliverables produced by GCDS, within his / her defined scope.
The Manager proactively engages with stakeholders inside and outside of GCDS to ensure standards and governance delivery in adherence to applicable processes, procedures, standards, and clinical program requirements.
The Manager is also responsible for the management and supervision of GCDS personnel. This includes responsibility for career development, performance objectives, ongoing performance feedback and recognition as well as annual performance appraisals for staff under his / her assigned area(s).
The Manager will also participate in recruiting, interviewing and selection of new hires.
Develops functional capabilities and ensures achievement of performance targets aligned with organizational goals and objectives
Contributes to and provide insights into implementation of strategic direction
In support of the Director, Delivery Management GCDS, ensures delivery alignment with established guidelines and targets
Drives timely, aligned delivery of quality standards and governance data management deliverables and services in support of our Company’s research pipeline
Manages employee performance, career development, and organizational talent and succession planning
Proactively engages with key customers and stakeholders on behalf of GCDS to recognize potential value-creating opportunities and to drive improvements in quality, efficiency, and productivity across the organization
actively engages in industry forums
Leads and participates in organizational initiatives as assigned
Supports audits and inspections as required
B.A. or B.S. degree, preferably in life sciences, information technology, or related discipline
Required Experience and Skills :
Minimum of 7 years’ experience in Clinical Data Management (or related discipline)
Minimum of 2-3 years’ experience in direct-line people management
Experience managing clinical data management processes including electronic Case Report Form (eCRF) design, clinical database development and validation, user acceptance testing, external data management, data extraction, and reporting
Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business functional areas
Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.
Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in the management of multiple projects.
Preferred Experience and Skills :
Knowledge of and direct experience implementing industry standards (e.g. Controlled Terminologies, CDISC CDASH, SDTM, ADaM, & HL7) and requirements for submission deliverables (e.
g., SDRG, ADRG, Define.xml)
Strong leadership and proven ability to drive results in a global, matrix environment
Ability to effectively collaborate and problem solve across both business and technical functions
Experience applying formal project management tools and processes
Experience building and / or developing an organization
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world.
We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.