Associate Director, Asset Lead, Clinical Data Sciences

ROLE SUMMARY

As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Asset Leadis responsible fortimelyandhigh qualitydata management deliverables supporting thecompanyportfolio. Responsibilities include delivery of asset level information strategies and services foroptimaluse and reuse of internal and external information that will advance research, development, and commercialization of thecompanyportfolio and further precision medicine. The Asset Lead is expected to manage large or several smaller assets and may directly or indirectly design, develop, and maintain key data management deliverables used to collect, review, monitor, and ensure the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Asset Lead may have direct reports.

ROLE RESPONSIBILITIES

• As needed, serve asClinical Data Scientist & Trial Leadfor one or more clinical trials assuming responsibility for all DMM activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence

• Act as the key scientific and technical data management expert; may define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as RBM standards, tools, data provisioning, and reporting

• Ensure work carried out by or on behalf of DMM isin accordance withapplicable SOPs and working practices.

• Serve asSubject Matter Expert (SME)for and oversees the design, documentation,testingand implementation of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems.

• Data Integrity planning and ongoing monitoring of conformance of data quality to plan over multiple assets, through the implementation of customize central data monitoring strategies usingappropriate toolsand analytics.

• Execution of clinical study data due diligence for acquisition/in-licensing and co-development deals, and clinical research collaborations asrequired.

• Key data management contact for regulatory inspections/audits in liaison with theappropriate Qualityand Safety groups.

QUALIFICATIONS

• Minimum 12 yearsClinical Data Management experience requiredincluding 5+years teamleadershipin pharmaceuticalindustry or CRO setting.

• Working knowledge ofall phasesof Clinical trials and ability to assess anddeterminestudy requirement from protocol review

• StrongProject and Risk Management

• Knowledge of Clinical Research, FDA & ICH, GCP, GCDMP, and related regulatory requirements

• Proficient experience using commercial clinical data management systems and/or EDC products (e.g.Medidata RAVE, Oracle RDC/ Inform,etc)

• Experience usingrelational databases (e.g.MS SQL Server, MS Access, or Oracle) and datavisualization tools (e.g.Spotfire,jReview)

• Familiarity with MedDRA/WHO-Drug coding

• Knowledge of risk-based monitoring principles and associated analytics/metrics

• Proven experience in vendor oversight to meet aggressive timelines ofhigh qualitydata deliverables

• Strong verbal and written communication skills; independently and effectively in multi-study, multi-disciplinary atmosphere inanmatrix environment

• Bachelor’sdegree required.Degree in scientific field preferred.Master’s degree preferred.