The opportunity
The Clinical Programming Lead Manager is responsible for managing timely and accurate execution of all start-up activities and milestone deliverables for all assigned clinical trial projects.
Clinical Programming lead manager is responsible for data definition by working with CRO and Third Party Vendors (TPV) to ensure receipt of data in Teva data standard format, generating the database transfer specification (DTS), receiving and processing study related data. This position is also responsible for providing professional expertise and leadership through leading departmental tasks and taking initiatives in improving data management processes with focus on Data Operations activities.
How you’ll spend your day
Essential Duties & Responsibilities:
Manages multiple projects
Likely to oversee contingent workers and/or vendors; Likely to provide training/ Mentoring to others
Ensures accurate set-up of data transfer processing
Delivers assignments with quality and within timelines
Provides strong programming support to CDISC based e-submission. Develops, debugs, and enhances SAS/ SQL programs to support to support study data batch processing and oversight listings
Responsible to define case report forms (CRFs) and external (non CRF) data specifications in accordance with CDISC guideline and Teva standards.
Responsible to define data flow and additional startup activities related to study initiation
Responsible to perform, supervise and manage day-to-day activities associated with receipt of clinical (CRF and non CRF) and operational (when relevant) data in accordance with study timelines
Responsible to perform data handling activities/unblinding activities on an ongoing basis to ensure accuracy, reliability, integrity, consistency and completeness of the data prior to database lock and providing the final data to clinical programming and statistics after database lock.
Supports collaboration, communication, coordination and prioritization within the department working in conjunction with Data Management Lead.
Responsible to follow Clinical Programming processes and perform programming activities related to clinical, external and operational data receipt and reporting to ensure the data meets Teva requirements and is reported with highest quality to all stakeholders
Pro-actively interacts and collaborates with different teams and provides necessary professional and programming support.
Participates in development of new SOPs/ Guidelines and Job Aids, as necessary
Initiates and leads new processes, new methodologies and operational ideas and re-challenges existing ones to improve the services provided, effectiveness, efficiency and faster turn around
Possible budget planning input
