Clinical Data Programming Lead

Clinical Data Programming Lead

Location – North Wales, PA

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.

The Clinical Data Programming Lead will be responsible for overseeing the set-up and maintenance of clinical data deliverables on multiple clinical studies.  The Clinical Data Programming Lead participates in activities as related to the specification, validation and quality assurance of study data deliverables and applies good 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 study specific programming setup, leading clinical data programming activities on multiple studies of simple to moderately complex design, with good 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.
• Quality assures programming outputs and support validation activities per the formal, documented QC process.
• Plans and works with the clinical programming group to schedule specification, programming and validation activities. Manages timelines for programming setup process, ensures issues are addressed in a timely manner to meet timelines and produces clinical data delivery validation packages for delivery to the study teams to file in the Trial Master File.
• Co-ordinates study database updates 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 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.
• 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 Service Group.
• To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participates in Data Management department initiatives.
• Plan for the study clinical data delivery in detail thereby providing clarity on all aspects of the setup progress.
• Maintaining all necessary study documentation for the clinical data delivery.
• Ensures all clinical data delivery queries are responded to in a timely manner. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is perused until resolved.
• Contributes to training materials on a process, system or technology level. Works with CTD and Clinical Data Services Management on delivery of training courses, instructor-led and on-the-job.
• Ensures programming processes are compliant with applicable SOPs.
• Ability to run existing programs to produce internal and sponsor deliverable.
• Other responsibilities may be assigned as required.

Role Requirements / Skills / Experience Required

• Bachelor’s degree, or local equivalent, in life sciences, business, technology, information technology, or related discipline.
• Minimum 4 years relevant clinical research data delivery experience.
• Demonstrated ability to produce CDISC and Sponsor defined clinical data deliverables.
• Experience with clinical data programming and the ability to review and evaluate clinical data.
• Extensive problem solving skills for tasks/functions related to his/her group.
• Strong organizational, prioritization and time management skills as to effectively organize workload and complete assignments.
• Ability to successfully manage multiple tasks and timelines.
• Ability to perform assigned tasks with little supervision.
• Ability to liaise professionally with team members.
• Team player with strong verbal and written communication skills.
• Demonstrated ability to learn new technologies, applications and techniques.

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 - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.