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Clinical Data Programming Lead

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About the role

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Clinical Data Programmer Lead
 
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  Our Clinical Data Programmer Lead is responsible overseeing the set-up and maintenance of clinical data deliverables on multiple clinical studies. They will participates in activities as related to the specification, validation and quality assurance of study data deliverables and applies competent experience and knowledge in support of the clinical data programmers assigned to a clinical study.
 
Overview of the Role
  • Serves as the clinical data delivery lead on multiple study specific programming setup, leading clinical data programming activities on multiple studies of simple to moderately complex design, with competent clinical data delivery experience and knowledge.
  • Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets.
  • Reviews specification documents created by study teams, such as data transformation specifications and programming specifications.
  • Co-ordinates and manages study database updates and out of scope impacts as specified per change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes.
  • Serves on project teams to coordinate and lead development activities for multiple clinical data programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
  • Trouble-shoots and solves study data delivery issues and/or external data integration issues and/or change request issues using the appropriate applications.
  • Plan for the study clinical data delivery in detail thereby providing clarity on all aspects of the setup progress.
  • Ensures high quality deliverables by providing senior review of study level/program-level/multi-study core deliveries for accuracy.
  • Attends sponsor audits and assists with in-progress audits, including presenting the Clinical Data Delivery process and procedures and pretending the validation documentation produced by the Clinical Data Services Group.
  • Ensures programming processes are compliant with applicable SOPs.
  • Ability to run existing programs to produce internal and Sponsor deliverables
  • Provide ongoing support, mentorship and training as appropriate, to members of the CDMS or CDS team involved
 
Role Requirements / Skills / Experience Required
  • Bachelor’s degree in information systems, science or related discipline.
  • Minimum 2 years experience building study databases or 4 years experience in clinical data programming
  • SAS Programming experience required
  • Proficiency in CDISC
  • Trained in Data Standardizing
  • Proficiency in Business computer skills
  • Documentation skills
  • Thorough knowledge of ICH Guidelines and GCP including regional regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing
  • Excellent oral and written communication and presentation skills.
  • In depth knowledge of clinical trial process and data management, clinical operations, and systems applications to support operations.
  • Demonstrated organizational skills to handle multiple competing priorities simultaneously across an assortment of projects and initiatives.
 
Benefits
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
 
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