Company:
Pharmaceutical Research Associates, Inc
Location: Emelle
Closing Date: 20/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Overview:
Working in ICON Strategic Solutions is more than a job, it’s a calling for people who care and have passion for improving patients’ lives. It takes courage to move from one job to another and the process involves careful consideration. At ICON, we care about our people as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.
All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you.
Responsibilities:
Services rendered will adhere to applicable the SOPs of the client, WIs, policies, local regulatory requirements, etc.
Provides expertise in planning, creation and oversight of clinical programming activities and deliverables from study set-up to submission ready CDISC SDTM tabulation packages (aCRF, define.xml, cSDRG, etc.).
Review and provide input into all trial set-up documentation.
Responsible for review or creation of aCRF, DTA metadata and trial design specifications.
Create or review mapping specifications for internal data and/or SDTM datasets.
Generate or review internal data and/or SDTM datasets using internal conversion framework, utilities, and global checks Ensure quality review of all datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for interim and final database locks.
Program, or oversee programming of, quality review checks and reports for use by Data Managers and other team members.
Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements.
Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml.
Support the development of standards and drive their implementation within the organization
What we offer :
Fully home based role within the EMEA region.
Full time permanent position
Part of a TOP 5 CRO (ICON Clinical), working within ICON ISS Unit (largest FSP unit) on FSP Basis for a well-known global biotech company.
Attractive compensation package & benefits; trainings and career development opportunities.
Benefits of Working in ICON Strategic Solutions:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Qualifications:
Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics, or another relevant scientific field (or equivalent theoretical/technical depth).
Minimum of 5 years of Clinical programming experience and experience working on a clinical trial.
Expert knowledge of SAS programming, Define.xml, SDTM aCRF, cSDRGs.
Expert knowledge of data structures (e.g., CDISC SDTM, ADaM) and their implementation.
Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
Project management skills.
Highly organized with excellent written and verbal communication.
Working in ICON Strategic Solutions is more than a job, it’s a calling for people who care and have passion for improving patients’ lives. It takes courage to move from one job to another and the process involves careful consideration. At ICON, we care about our people as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.
All our team members have the independence to get the job done with support from the experienced leadership team when you need it. If you want a career with a difference, ICON Strategic Solutions is the place for you.
Responsibilities:
Services rendered will adhere to applicable the SOPs of the client, WIs, policies, local regulatory requirements, etc.
Provides expertise in planning, creation and oversight of clinical programming activities and deliverables from study set-up to submission ready CDISC SDTM tabulation packages (aCRF, define.xml, cSDRG, etc.).
Review and provide input into all trial set-up documentation.
Responsible for review or creation of aCRF, DTA metadata and trial design specifications.
Create or review mapping specifications for internal data and/or SDTM datasets.
Generate or review internal data and/or SDTM datasets using internal conversion framework, utilities, and global checks Ensure quality review of all datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for interim and final database locks.
Program, or oversee programming of, quality review checks and reports for use by Data Managers and other team members.
Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements.
Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml.
Support the development of standards and drive their implementation within the organization
What we offer :
Fully home based role within the EMEA region.
Full time permanent position
Part of a TOP 5 CRO (ICON Clinical), working within ICON ISS Unit (largest FSP unit) on FSP Basis for a well-known global biotech company.
Attractive compensation package & benefits; trainings and career development opportunities.
Benefits of Working in ICON Strategic Solutions:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Qualifications:
Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics, or another relevant scientific field (or equivalent theoretical/technical depth).
Minimum of 5 years of Clinical programming experience and experience working on a clinical trial.
Expert knowledge of SAS programming, Define.xml, SDTM aCRF, cSDRGs.
Expert knowledge of data structures (e.g., CDISC SDTM, ADaM) and their implementation.
Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
Project management skills.
Highly organized with excellent written and verbal communication.
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