Jobs at Synteract

The Statistical Programmer provides programming support to the Biostatistics and Clinical Programming functions. He/she develops, creates, verifies/validates and maintains the programs for assigned projects in compliance with standard operating procedures. At higher levels the statistical programmer roles are expected to contribute to the improvement of overall department process and efficiencies through mentorship and identifying and contributing to departmental initiatives.

Specific Tasks Would Include

• Create and maintain SAS programs for safety analysis datasets (including SDTM, ADaM, and other analysis datasets) and safety tables and listings used in the analysis and reporting of clinical trial data.
• Perform programmatic validation of safety SDTM datasets and data listings used in the reporting of clinical trial data.
• Create and review Pinnacle 21 reports and investigate as necessary.
• Maintain study documentation according to Standard Operating Procedures.
• Document and communicate data issue findings to data management through recording them in the data issue log.
• Awareness of time available to complete tasks and work with study lead and manager to manage effort.
• Assist with ad-hoc programming as requested.
• Regularly participate in ongoing department training and development opportunities.

Degree And Experience

• Bachelor's degree or equivalent in mathematics, statistics, or related field of study and some related experience or equivalent combination of education and experience.

Specific Knowledge

• Possesses a basic knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
• Basic proficiency in BASE SAS or other statistical software is advantageous, but not required. Statistical Programmer levels
• Understands the sequence of running programs to ensure up-to-date data, to troubleshoot and debug programming problems, and to identify data trends.
• Proficiency in Microsoft Word, Excel, PowerPoint, Access, and Outlook.
• Effective verbal and writing skills; English + local language, if relevant.

go to method of application »

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

go to method of application »

The Medical Writing Editor is responsible for providing technical writing and editing support of various regulatory and clinical research technical documents, including clinical trial protocols, clinical study reports, informed consent forms, investigator’s brochures, and other regulatory documents. Copy editor duties are focused on proofreading documents for text, content, and syntax consistency to facilitate the successful production and completion of such deliverables with quality. Provides communication support between medical writers, internal personnel, and clients. Provides quality review (QR) of documents as well as document finalization. Performs literature and reference research activities to support medical writers and regulatory professionals

Specific Tasks Would Include

• Primarily reviews, proofreads, edits, updates, corrects, formats, and makes improvement suggestions for project-related clinical study documents.
• Reviews material for grammar, spelling, punctuation, correct medical terminology, typographical errors, and formatting.
• Checks accuracy of content and ensures style consistency.
• Verifies data against original sources for quality control.
• Verifies correct implementation of internal and client changes.
• Ensures timelines are promptly met.
• Assists in compiling documents into a final product.
• Takes the initiative to be proactive and search out tasks before they are given.
• Performs data/content verification and reference checks information as required.
• Adheres to Synteract Style Guide, AMA style guidelines, or sponsor preferences.
• Interacts with internal specialists and Synteract consultants when appropriate.
• Participates in corporate initiatives and actions that ensure the continued success of the company.
• Provides a variety of technical skills, especially in programs such as Microsoft Office and Adobe Acrobat.
• May develop and maintain macros-enabled document templates.
• Maintains working knowledge of applicable industry guidelines and regulations.
• Maintains working knowledge, reviews, and updates departmental controlled documents as required.
• Other activities as designated.

Qualifications

• Bachelor’s degree or its international equivalent from an accredited institution.
• Scientific/technical background preferred.
• 2 to 4 years of related experience (clinical trials, publishing, writing, or editing), with at least three years of medical editing experience in a regulated environment, preferably in the pharma/biotech/CRO sector.
• Experienced in Microsoft Office and Adobe Acrobat.
• Working knowledge of GCP, ICH and FDA Guidance Documents/EU Directives/ISO14155 regulations and/or drug/device development.
• Demonstrated knowledge of web-based communication tools and various technical programs, including but not limited to Adobe, Microsoft Office, etc.
• Strong knowledge of AMA style guidelines.
• Demonstrated mastery of grammar, punctuation, and spelling.

go to method of application »

The Medical Writer is responsible for writing, editing and reviewing clinical study documents according to global regulatory guidance, templates, style guides and standard operating procedures (SOPs). Clinical study documents may include but are not limited to study protocols and amendments, investigator brochures (IBs), informed consent forms (ICFs), annual safety reports, clinical study reports (CSRs), Integrated Summaries of Safety and Efficacy (ISS/ISE), and other sections of regulatory applications (IND, IDE, NDA, BLA and PMA submissions). Other scientific documents (including but not limited to manuscripts, abstracts, posters) may also be developed.

Specific Tasks Would Include

• Interpret clinical study results and write, review and/or edit clinical study documents
• Perform quality reviews on documents developed by other writers
• Prepare scientific manuscripts, abstracts, posters
• Review scientific literature, product information and evaluate product data
• Assist with writing and/or reviewing SOPs
• Serve as the primary point of contact for MW on project teams
• Conduct activities within budget and timeline requirements

Qualifications

• Degree in a scientific or medical discipline and 2-4+ years’ experience or equivalent combination of education and experience. Advanced degrees (e.g., PhD, MS, MPH) preferred.
• Familiarity with relevant ICH, GCP, CTD/eCTD and FDA guidances,
• Familiarity with medical terminology
• Excellent proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer and Adobe Acrobat.
• Effective verbal and writing skills; English

go to method of application »

As a SAS Programmer, you will be responsible for executing programming activities in coordination with project teams with supervision. You 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. Review objects and registry of SAS datasets. SAS programs used to generate random samples of subject numbers and calculate database reliability rates during the quality control of paper-based project databases. 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 the relevant field of study or B.S. equivalent.
• 2 years of experience in clinical research preferred.
• 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.
• Basic proficiency with Microsoft Office: Word, Excel, Outlook, PowerPoint.
• Effective verbal and writing skills; English + local language, if relevant.