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Principal Clinical Programming Analyst

Iconma Llc

This is a Contract position in Covington, LA posted November 20, 2021.

Job Description Position: Principal Clinical Programming Analyst ,Req: 13305149 Location: Irvine, CA, Remote Duration: 6 Months Contract Schedule Notes: Prefer a local candidate but am open to Remote anywhere in the U.S.

The core time working should be 8 am-4 pm PST.

Remote flexibility.

If the candidate is local
– the team would want them to come onsite occasionally, as needed.

Job Description: Education and Experience: Bachelor’s Degree required with 10 years of previous related experience in clinical research, data management, software programming, or related field Required Master’s Degree is preferred with 8 years of previous related experience in clinical research, data management, software programming, or related field Required SAS Programming is Required
– minimum of 5 years Experience with relational databases and database building
– minimum of 10 years Report building experience
– minimum of 10 years Good programming documentation processes and knowledge of FDA requirements for programming documentation Preferred experience with Medidata RAVE, Oracle Clinical/Oracle databases Preferred experience with Custom Function and Python
– minimum 3 years of experience Ability to manage competing priorities in a fast-paced environment Ability to work independently with minimal supervision Excellent communication, written and verbal, and comfortable speaking to data and discrepancies Key Responsibilities: Lead the development of highly complex clinical databases, and tools and programs for data validation checks, and clinical trial reporting (25%) Act as an SME on core business software solutions (e.g., RAVE, EDC system, CTMS) to provide novel end-to-end software solutions that improve, automate, and solve complex business process challenges (20%) Plan and lead the design and implementation of complex functional modules and provide clinical programming expertise regarding clinical trials, protocols, and case report forms with cross-functional teams (19%) Lead the development of specifications for complex systems and/or processes, system upgrades/enhancements, and integration; and engage IT to deliver higher-level support to users (15%) Plan, organize and manage internal and external clinical systems resources and activities to support clinical trials in accordance with regulatory and company guidelines.

Direct the specification, documentation, validation, implementation, data archiving, and retirement activities of clinical databases for clinical studies.

Collaborate with cross-functional teams to provide functional support to clinical study projects.

(10%) Train and mentor internal staff to ensure the efficient operations of the clinical programming function in cross-functional projects.

(5%) Provide guidance in the creation and revision of new or existing SOPs, work instructions, workflow, forms, and templates to ensure clinical systems and activities are in compliance with the regulatory and company requirements.

(5%) Manage internal resources and activities to facilitate collaboration with external vendors (1%) LI-FRESH