Process and Technology Manager - The Ashlar Group

The Process and Technology role is responsible for providing technical leadership and process ownership for Data Sciences and Solutions. These are the broad applications/focus areas for this role:
• Apply specialized process/technology knowledge to ensure clinical trial deliverables are consistent and accurate
• Act as a primary contact within the Data Sciences and Solutions organization for development and support of process and technology
• Communicate and adhere to the global data strategy across the organization as it relates to process and technology
• Focus area: Leadership and execution of data movement activities for Data Sciences and Solutions in partnership with Statistics and Real World Evidence functions. This role would accomplish data delivery/data movement through internal and COTS ETL tools and business processes. Process improvements and developing new processes/tools will be a part of this role's responsibilities.

Responsibilities Process/Technology Strategy Support (40%)
• Define, deliver, and continuously improve global processes and/or technology to facilitate the reliable planning and execution of deliverables
• Assist during the design and execution of clinical trials to ensure the development of the trial is consistent with the global data strategy, as applicable to focus area
• Identify, monitor and communicate global customer needs/requirements related to process and/or technology performance and enhancements
• Ensure process and/or technology interfaces are optimized across Biometrics and Advanced Analytics
• Provide business case analysis as needed for Biometrics and Advanced Analytics initiatives, as applicable to focus area
• Support the identification, communication, maturation and adoption of best practices and global standardized business processes, as applicable to focus area.
• Marry deep phase/TA/geography expertise with deep process and/or technology expertise, as applicable to focus area.
• Manage projects/process/technology that span across multiple functions/vendors/other external organizations, areas of focus are InForm/CIS/Central Designer, Clintrial Integrations and CTMM Integrations, Submissions, Integrated Databases, MedDRA/WhoDRUG/SAE in InForm/LSS and other systems.
• Partner and/or strengthen relationships between key providers or customers, including influencing statisticians, statistics COE, physicians, clinical pharmacology and clinical operations etc, as applicable to focus area.
• Define, measure and achieve group proficiency with new tools/technology, processes, and the application of best practices as applicable to focus area

Business Office Support (40%)
• Partner with LRL Financial and Procurement to manage budgets, invoice processing and payments, work orders and contracts
• Provide guidance and consulting into forecasting expenses
• Develop, track and maintain business office metrics
• Build and maintain effective business partnership with teams, functions and affiliates understanding needs and ensuring timely response
• Define and provide guidance related to vendor management
• Provide business case analysis as needed for Biometrics and Advanced Analytics initiatives

Process Improvement (15%)
• Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
• Represent Data Sciences' processes in cross-functional initiatives
• Actively participate in shared learning across Clinical Data Flow and Technology
• Work with partners to increase vendor/partner efficiencies

Asset Protection (5%)
• Understand the confidential nature of company information and takes necessary steps to ensure its protection. This includes understanding various aspects of Privacy as it relates to the data managed within Clinical Data Flow and Technology.
• Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to CROs or other outside parties
• Accept obligation to Lilly for compliance to the integrity of the company
• Complete readings of any policy/procedure updates including global medical, Clinical Data Flow and Technology, and local policies and procedures

Additional Skills/Preferences
• 3 years experience in clinical data management and/or 5 years experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, etc.)
• Demonstrated knowledge of data management processes and technology
• Demonstrated ability to understand and apply data flow, data quality, data interchange, data mining, and data representation principles
• Knowledge of global internal, external and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI etc.)
• SCDM certification
• Strong interpersonal and leadership skills
• Excellent oral and written communication skills
• Interpersonal/teamwork and communication skills for effective customer consultation
• Strong business acumen
• Demonstrated strength in logical thought, problem solving ability and strategic thinking
• Ability to communicate and influence within Clinical Data Flow and Technology
• Domestic and International travel may be required.

Basic Qualifications
• Bachelor's degree
• Qualified candidates must be legally authorized to be employed in the United States.