Ref #: 32240

Employment type: Permanent - Full-Time

Location: Home based in Europe

Posted: 17-Sep-2021

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.


Key Responsibilities:

• Initiate SDTM Kickoff meeting with study management team (SMT)
• Set up monthly “Data and SDTM review meetings” for which “Data and SDTM findings log” will be source. Lead will go over the Data issues and get any SDTM findings from SMT team.
• Annotate SDTM CRFs
• The Lead SDTM is also responsible for writing dataset specification and As needed work on Key Domains
• Applies extensive domain and therapeutic knowledge in the programming of SDTM datasets to ensure quality and accuracy.
• The Lead SDTM may lead and execute multiple projects in parallel, including ongoing coaching and mentorship of individual team members.
• Lead SDTM manages task assignments and makes sure that all the support programmers are utilized as needed across multiple projects without compromising quality and timelines of any deliverables
• Collaborate with key stakeholders to understand dataset requirements for SDTM production
• Lead SDTM may answer all questions from study team (Analysis, Biostatistician and programming) and set up any meetings as needed.
• Validate datasets using P21 and provide solutions to the issues and deliver high quality datasets.
• Generate & Validate SDTM Define.xml and provide justifications for any outstanding issues
• Key contributor to SDRG (Study Data Reviewer’s Guide)
• Submit SDTM governance requests for review by Standards SMEs
• Communicates with key stakeholders to aid in further development of SDTM standards and process



To be successful in the role, you will have:

• At least 5 years of relevant experience in pharmaceutical industry is desired
• University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree
• In-depth knowledge of protocol, current clinical drug development processes.
• Expert programming skills SAS including SAS® LSAF, SQL or other languages R, Python, etc.
• Expert knowledge of SAS programming, Define.xml, SDTM aCRF, cSDRGs.
• Expert knowledge of data structures (e.g., CDISC SDTM, ADaM) and their implementation.
• Ability to work with cross-functional team interpreting data requirements.
• Strong project management skills and knowledge of team management principles are required.
• Excellent written and verbal communication skills.
• Ability to liaise successfully with team members, management and externally with vendors and sponsors, as required.
• Advanced problem solving and organizational skills, attention to detail, verbal and written communication skills.
• Excellent understanding of global clinical trial practices, procedures, methodologies and regulatory requirements (e.g., GCP, ICH).
• Ability to critically review data and implement corrective action steps effectively.


To apply:
Would you like to know more? We are looking forward to your application by either submitting your CV via email to anja.potrafke@docsglobal.com or apply via our career portal on www.docsglobal.com. We are looking forward to hearing from you.


Benefits of Working in ICON:
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.
#sasjob