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Senior Clinical Programmer
2 months ago
The Principal Clinical Programmer is responsible for overseeing and coordinating programming tasks across multiple clinical studies. As a seasoned expert in data management programming, this role provides essential technical guidance and support to the data management team. The individual may supervise the output of other programming professionals, ensuring adherence to high standards of quality and timeliness.
Key Responsibilities:
- Possess a comprehensive understanding of SQL programming principles and the capability to develop intricate SQL code.
- Configure studies/projects utilizing ETL tools and create complex SQL queries for report generation.
- Integrate data from various sources and external applications through ETL tools.
- Demonstrate an in-depth understanding of the clinical trial process from Phase I to IV.
- Experience in the Clinical Data Management sector is crucial.
- Thorough knowledge of data management activities related to studies, including CRFs, reconciliation, and manual data reviews.
- Ability to comprehend departmental SOPs and WIs.
- Familiarity with GxP systems and the regulatory framework governing clinical systems.
- Capable of independently managing clinical studies within CDSM with minimal oversight.
- Collaborate effectively with stakeholders in CDSM, including data managers and review teams, to provide necessary programming insights and solutions.
- Track clinical study milestones and ensure timely report delivery.
- Communicate clearly and concisely in departmental and study team meetings, articulating programming-related issues and concerns.
- Develop programming guidelines and documentation as required.
- Offer innovative programming solutions to address daily study and data management challenges.
- Employ systematic approaches to problem-solving and proactively identify potential risks and issues.
Required Knowledge and Skills:
- High proficiency in programming languages relevant to Clinical Data Management Systems (CDMS) such as SAS/ETL and SQL Plus, along with a solid understanding of data standards like CDISC and SDTM.
- Extensive knowledge of Clinical Data Management processes, including Good Clinical Practices (GCP) and regulatory requirements such as 21 CFR part 11.
- Strong organizational, presentation, documentation, and interpersonal skills, complemented by a collaborative team-oriented mindset.
- Demonstrated experience in clinical programming, clinical data management, and data reporting, with proficiency in languages such as SAS and SQL.
- Ability to independently assess and implement the most suitable methods and procedures across Clinical Data Management projects.
- Exhibit strong written and verbal communication skills, capable of conveying complex technical information to diverse audiences and fostering consensus around issues.
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