Works with clinical data management systems and programming tools to provide technical leadership in data management activities and deliverables including, but not limited to, database development and data validations. Acts as a leader within a multi-disciplinary project team to complete assigned tasks on time and within budget. Serves as technical knowledge expert and provides leadership across departmental processes and projects. Supports management in oversight of study day to day activities and identification/creation of needed tools and process improvements to increase efficiencies within the project and the team
Independently performs tasks following within the timelines established by the team, in accordance with the process outlined in the departmental procedures and indicated by the project contract.
Defines and imports data into the system.
Proficient in understanding Listing requirements and Listing Development process
Defines, creates, and tests listings for data review and performs programming activities in line with project requirements using SAS.
Create DTAs based on standards guidelines and perform Data Transfers
Proficient in Reconciliation listings, specialized reports like patient profiled, MPRs, SSTs and SAE Reconciliation.
Good understanding of Dat Extraction process from various EDC Systems
Research and leverages resources to resolve issues and manage moderately complex tasks through the development and application of new knowledge and/or professional skills in areas including programming and technology and leadership of project team in delivering tasks.
Assumes primary responsibility and technical leadership, demonstrating a good understanding of the role in the overall process.
Trains, mentors, and coordinates the activities of junior programmers.
Participates in departmental or corporate process initiatives.
Contributes to the creation and validation of reporting tools / standard applications / enhanced processes, and works with IT in troubleshooting, reporting, and resolving system issues.
Qualifications:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
5+ Years of expereince in SAS, Data Listing Related activities
Knowledge, Skills and Abilities:
Strong written, verbal and computer skills
Demonstrated leadership skills and the ability to work and communicate effectively on a multidisciplinary team with a positive attitude, enthusiasm toward work, and capable of mentoring and working well with others
Demonstrated organizational and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Proficient in one or more programming languages
Proficient in relational database systems (RDBMS) and structure
Proficient in programming tools SAS, SQL, Crystal Reports, SpotFire and JReview
Strong presentation, interpersonal, and problem solving skills
Capable of attaining, maintaining and applying a working knowledge of GCPs and applicable SOPs
Demonstrated ability to make recommendations for process development and improvement
* Demonstrated skill in identification and resolution of technical problems in a professional environmen
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