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 Lead is responsible for timely and high quality data management deliverables supporting the company portfolio.  Responsibilities include delivery of asset level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the company portfolio 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 as Clinical Data Scientist & Trial Lead for 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 is in accordance with applicable SOPs and working practices. 

• Serve as Subject Matter Expert (SME) for and oversees the design, documentation, testing and 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 using appropriate tools and analytics. 

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

•  Key data management contact for regulatory inspections/audits in liaison with the appropriate Quality and Safety groups. 

QUALIFICATIONS  

• Minimum 12 years Clinical Data Management experience required including 5+ years team leadership in pharmaceutical industry or CRO setting. 

• Working knowledge of all phases of Clinical trials and ability to assess and determine study requirement from protocol review 

• Strong Project 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 using relational databases (e.g. MS SQL Server, MS Access, or Oracle) and data visualization 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 of high quality data deliverables 

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

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