Senior Clinical Data Management

Job Description

Senior Clinical Data Management Programmer

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Leads in the evaluation, implementation and validation of package systems to support Clinical Database review requests of all Clinical Database applications. Creates, maintains and oversees process for providing end user support for all Data review and ad hoc listings. Works very closely with Clinical Data Managers to develop study specifications listings and gain acceptance through user testing. Develops data quality listings to comply with related specifications and regulatory requirements. Processes database programming change requests. Documents all work fully according to FDA regulations and guidance, and company SOPs. Communicates programming and related document review statuses to management and the project teams.

Primary Responsibilities

- Lead the development, validation, and maintenance of clinical reporting of clinical trials using a variety of validated software applications
- Provide complete and accurate documentation of study databases consistent with company standard operating procedures (SOPs), study protocols and related data management documentation
- Develop a variety of SAS/Data review/Visualization reports by integrating various sources of Data for efficient Clinical Data review and decision making
- Implement and test data quality checks in accordance with the study database specification listings
- Manage and develop programs for the reconciliation of external data from vendors (e.g., central lab data)
- Serve as SME and facilitate integration of EDC systems to other clinical platforms such as CTMS, Reporting, and IRT as needed
- Assist in managing and providing listings to all medical coding dictionaries, including but not limited to MedDRA and WHODrug
- Oversee the management of Clinical report development, other GxP system user accounts and other help desk activities within Clinical reporting areas
- Develop EDC report listings, work with EDC vendors to resolve, and escalate issues appropriately to Senior Management
- Work very closely with other functions to support ad hoc report development using tools such as Python, R Programming, Power BI, etc
- Quickly learn new and/or advancements in software to become the SME for any technical question
- Demonstrate good problem-solving skills, a proactive approach, and a willingness to make decisions, seeking advice when necessary
- Facilitate and/or participate in writing departmental documentation (e.g., training documents, process guidance)
- Keep management team abreast of issues, progress, and risks related to trial operations
- Support bid defenses from a technical SME perspective
- Providing proactive ideas, support developing Insightful reports for supporting Data review process,
- Participate in other clinical programming and data management activities, as required
- Participate in internal and external team meetings, as required
- Mentor junior level clinical programmers
- Adhere to all aspects of the Statistics & Data Corporation&aposs quality system
- Comply with Statistics & Data Corporation&aposs data integrity & business ethics requirements
- Perform other related duties incidental to the work described herein
- Adherence to all essential systems and processes that are required at SDC to maintain compliance with business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

Required Skills

- Excellent understanding of relational database structures
- Fast, accurate programming skills using assorted application software
- SAS, R Programming, Python, PL/SQL, SQL, and XML programming skills
- Solid interpersonal skills, with the ability to work well with people of all levels of expertise and comfort in varied organizational relationships
- Demonstrated ability to provide both 'user-friendly' and technical documentation
- Good time management and organization skills, including the ability to work in an efficient manner and prioritize tasks to meet tight deadlines while maintaining the highest standards of work
- Ability to provide expertise to guide department in continued efficiency and growth
- Knowledge of FDA regulations and guidance (e.g., 21 CFR Part 11, ICH/GCP)
- Knowledge of installation and/or validation of clinical data management system (CDMS) applications in a clinical research environment
- Good knowledge of industry standard EDC tools (Medidata Rave, iMedNet, Viedoc, Veeva, etc.)
- Knowledge of Reporting application development (e.g., JReview, Business Objects, Python, PowerBI) is required

Education Or Equivalent Experience

- Bachelor&aposs degree in computer science or other quantitative or scientific discipline with 6+ years&apos experience in database programming and demonstrated working knowledge of scientific principles
- At least 6 years&apos experience assuming lead report programming responsibilities on projects, with a minimum of 4 years in a clinical environment
- Experience with FDA regulations and guidance is required

Benefits

Why SDC

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

- We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits
- We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment
- We strive to provide a place of belonging to our employees with fun and engaging activities from SDC&aposs culture club
- We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry
- With a proven track record, SDC has been successfully executing client clinical programs since 2005

Take a look at how you can join our team

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