Head Clinical Data Solutions
Proclinical is currently recruiting for a Head of Clinical Data Solutions with a global pharmaceutical company located in Boston, MA. Successful candidate will lead and organize the Global Development Operations technology systems strategy, in collaboration with preferred vendors, therapeutic area units and IT, to support the timely and efficient delivery of global development programs with high quality and within allocated budget.
- Data collection/extraction strategy and alignment with clinical protocol / industry data standards. Including oversight of CRO-led implemention, execution and delivery of clinical data.
- Develop, implement, and oversee an operational data ownership strategy in support of global development projects and marketed products for all therapeutic areas.
- Drive strategy to ensure compliance to CDISC standards for all development programs and marketed products to ensure regulatory submission compliance.
- Provide insight on latest technologies and changes in regulatory environments, enabling proactive approach and planning to meet future requirements and efficient study and data management support of global development programs.
- Strategic planning, resourcing, oversight of data deliverables including design and implementation of data capture tools, data processing, coding, validation, data quality.
- Archival and inspection readiness of data management TMF documents.
- Data management representation on clinical subteam.
- Ensure the vendor's technology processes meet or exceed the regulatory requirements to support the company's global development projects, marketed products, Vaccine Business unit and Local Operating Companies (LOCs).
- Partner with preferred vendors and functional areas such as Quantitative Science, CMCC and IT to drive technology improvement and innovation to enhance data capture and clinical trial management efficiency and data quality.
- Responsible for planning and management of external budgets related to data technology licensing, hosting and deliverables.
Skills and Requirements:
- BS degree in Computer Science, Life Science or other technical field required; advanced degree desired.
- 10+ years of applicable informatics, systems and /or relevant drug development experience; global experience and experience in drug development strongly preferred.
- 8+ years of project management and leadership experience.
- Knowledge of general database programming and computing principles, common software products and technologies used in drug development.
- Ability to develop and evaluate business cases and effectively manage budgets.
- Good knowledge of FDA and ICH regulations and industry standards applicable to drug development systems.
- Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy.
- Senior management experience in Clinical Data Management or related field, leading a medium to large organization and influencing senior-level management and key stakeholders.
- Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
- Operational experience in pharmaceutical drug development with significant direct exposure to clinical development.
- Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.