Director, Global Data Management Service Delivery
Key tasks :
Providing operational leadership to the delivery of work performed in India through preferred service provider(s) supporting global data management activities (i.
e. clinical data management, clinical data acquisition and standards, clinical data reporting and analytics, and medical coding).
Partnering with other leaders in Global Data Management and Centralized Monitoring to ensure delivery of complete, high quality and reliable clinical trial information that enables internal decision making, regulatory approval and market acceptance.
Collaborating with global clinical trial planning and alliance management to ensure clearly defined and effective governance of service provider(s) supporting global data management based in India.
Ensuring service level agreements for global data management work performed in India are defined, redefined as necessary, and reviewed on a regular basis.
Where service levels are not met, actions are defined to address.
Ongoing partnership with other leaders in Global Data Management and Centralized Monitoring to ensure consistent understanding by service provider staff of global data management processes, providing training to staff as necessary.
Understanding industry evolution to provide insight in the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.
Focusing on continuous improvement, defining and implementing the changes required to create an industry-leading clinical data capability in India, including electronic data capture, external data integration, ad-
hoc analysis and end-to-end data standards.
Ensuring adaptive management of the India service provider team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of Company products.
Representing the Company in interactions with key external partners as part of any committee or industry group relating to data management and centralized monitoring.
Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his / her views to senior management.
Engaging and energizing service provider staff through communication of Company goals, priorities and other business critical information as well as focus on service provider value proposition.
Helping to develop and promote a work place culture that values diversity of thought, promoting integrity and creating an atmosphere that fosters accountability.
Experience and expertise required :
Bachelor’s degree required with an advanced degree preferred. At least 8 years of relevant industry experience, with substantial experience of managing staff in a Business Process Outsourcing (BPO) service model.
Significant global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices.
Immuno-Oncology therapeutic experience is highly desirable.
Expert knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
A good understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
Strong technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
Strong experience in data management and well versed in industry trends and emerging industry dynamics concerning data review.
A strong understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.
Demonstrated partnership across various collaborative forums, CROs, SMOs and / or local site networks.
Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)
Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.
Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a large, geographically diverse team.