Fresh Jobs at Synteract

Position Overview

• The SAS Programmer is responsible for executing programming activities in coordination with project teams with supervision. S/he will develop, create, verify/validate and maintain managing the programs for assigned projects in compliance with standard operating procedures.

Specific Tasks Would Include

• Participates in the validation of SAS programs and maintaining validation documentation.
• Familiarizes oneself with the SAS dataset structure and format catalog related to a given study.
• Familiarizes oneself with the documents associated with a given study.Such documents include (but are not limited to) edit check documents, SAS and database annotated Case Report Forms (CRFs), visit map/schedule of events, CRFs, code lists, statistical analysis plan (SAP), data management plan (DMP), clinical protocol, programming-specific documentation.
• Develops, programs and maintains:
  • SAS edit checks and SAS edit check listings.
  • Subject profile programming used for quality control of paper-based project databases.
  • Data line listings as requested by the Sponsor and/or internal project teams.
  • Clean subject programming used to identify clean subjects for a given project.
  • JReview objects and registry of SAS datasets.
  • SAS programs used to generate random samples of subject numbers and calculate database reliability rate during the quality control of paper-based project databases.
  • Study Data Tabulation Model (SDTM) dataset programming.
  • Programs that download external data received from various data sources.
  • External data reconciliation programs.
  • Programs that generate CRF and Query metrics.
  • Ad-hoc Sponsor and internal programming requests.

Qualifications

• Bachelor’s degree in a relevant field of study and 0-2 years data management or SAS programming experience or equivalent combination of education and experience.
• Possess an underlying understanding of data management practices and clinical data management systems (CDMS).
• Possess a basic understanding of the Clinical Data Interchange Standards Consortium (CDISC) domain and item names and the role of CDISC in drug development.
• Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends.
• Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
• Effective verbal and writing skills; English + local language, if relevant.

If you’re passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.

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Position Overview

• The Clinical Programmer is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. S/he supports the clinical teams, sponsors, statisticians, safety egulatory, analytical programmers, and clinical data management personnel.

Specific Tasks Would Include

• Maintains the full-scope of responsibility for assigned projects: ensures on-time delivery, communicates the status of projects to internal teams and study sponsors.
• Provides programming for the Company’s internal applications, client-related projects and third-party applications.
• Develops, tests, and validates programs to support client-related projects and third-party applications.
• Provides technical support services for internally developed applications, client-related projects and third-party applications.
• Troubleshoots and resolves software related problems.
• Follows standards for data integrity and data security.
• Assists with the creation of validation documents including Installation Qualification, Operational Qualification and Performance Qualification scripts.

Qualifications

• Bachelor’s degree in Computer Science or related field of study or B.S. equivalent.
• Experience in EDC- Rave Building, Migrations, and Custom Function programming preferred.
• Understanding of source control is preferable.
• Some applicable experience desired, but not required.
• Basic understanding of computer operating systems.
• Basic proficiency in one or more of the following programming languages: Java, Javascript, C#, PHP, Perl, Python, C++, PL\SQL, Transact SQL.
• Basic proficiency with a relational database system: SQL Server, Oracle, MySQL.
• Basic proficiency with Microsoft Office: Word, Excel, Outlook, PowerPoint.
• Effective verbal and writing skills; English + local language, if relevant.

If you’re passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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Position Overview

• The Clinical Data Manager (DM) is responsible for the coordination and delivery of Data Management contracted services on assigned projects. This includes meeting internal and external sponsor requirements according to time, quality, scope and budget parameters. The DM is the primary point of contact for Data Management on a project, for internal project team members, sponsors, and external data vendors. The DM presents project-related training, and may provide technical guidance and direction to team members.

Specific Tasks Would Include

• Serves as the primary Data Management interface for internal project team members, sponsor representatives, third party CROs, and external data vendors.
• Ensures the timely initiation, conduct, and completion of Data Management activities on clinical trials.
• Leads a sub-team of Data Management staff members assigned to a project.
• Tracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverables.
• Authors the Data Management Plan (DMP), outlining all data management responsibilities.
• Authors the Data Transfer Agreement (DTA) with third party external data vendors
• Oversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a project.
• Conducts project-specific training throughout the course of the project, as needed.
• Attends and presents at client bid defense meetings.
• Attends and presents at project meetings as required.
• Oversees the completion of a comprehensive data review of clinical data.
• Ensures medical coding is performed in a timely manner
• Ensures DM documentation is audit-ready and filed appropriately at all times.
• Coordinates all activities in preparation for database lock, including Data Review Meeting.
• Oversees the production of status or progress reports, listings, and other output as required during the course of the project
• Monitors budget and scope of work for contracted DM services throughout the duration of the project, identifying out of scope or budget activities, and collaborating with the project manager when out of scope documentation and costs are needed.

Qualifications

• Bachelor’s degree in a related field of study or equivalent combination of education and work experience
• Minimum 2 years experience in clinical research
• Demonstrated experience in a lead role
• Knowledge of ICH/GCP standards, 21 CFR Part 11.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
• Effective verbal and writing skills; English + local language, if relevant.
• EDC experience; knowledge and experience with Rave desired

If you’re passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.