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Clinical Data Delivery Lead - Permanent Job

Company Name:
Arca24.com
Salary period: Annual
Clinical Data Delivery Lead needed for a Direct Hire opportunity with Yoh's client located in North Wales, PA.
What You Need To Bring To The Table:
- Manage multiple clinical data delivery projects in accordance with established timelines, budget, quality standards and/or contractual requirements.
- Participate in activities as related to the specification, validation and quality assurance of study data deliverables and applies expert experience and knowledge in support of the clinical data programmers assigned to a clinical study.
- Provide support to and acts as a back-up for Clinical Data Delivery Manager. To effectively assist the Clinical Data Delivery Manager or designee in leading the activities for those under his/her jurisdiction in a manner that ensures all timeframes and targets are met and that costs are kept under control.
- Recognize, exemplify and adhere to values which centers around our commitment to People, Clients and Performance.
- Travel (approximately 15%) domestic and/or international
- Serve as the clinical data delivery lead on multiple study specific programming setup, leading clinical data programming activities on multiple studies of complex design, with expert clinical data delivery experience and knowledge.
- 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, validation and ongoing delivery 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.
- 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.
- May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data delivery, to determine scope and limitations of the study and to discuss opportunities for innovative clinical data delivery.
- 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.
- Participates in special projects or tasks related to the clinical data delivery as directed by the Clinical Data Delivery Manager, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress.
- 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.
What You Need to Bring to the Table:
- Bachelor's degree in information systems, science or related discipline or relevant experience required.
- Minimum six (6) years relevant clinical research data delivery experience.
- In depth proven clinical research data delivery
- 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.
Opportunity is Calling, Apply Now!
Recruiter: Krista Leach
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.
J2W: CLINICAL
MONJOB
J2WNECLIN
Ref:
SFSF: LS

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