Clinical Data Programmer Jobs in California (NOW HIRING)

Job Summary:
RIT Solutions, Inc. is a company focused on clinical data management, and they are seeking a Data Acquisition Specialist. The role involves managing the acquisition of external clinical data, ensuring alignment with company standards, and developing relationships with key stakeholders in the clinical trial process.
Responsibilities:
• Serve as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level and manage study start up, conduct and close out activities.
• Create external data transfer agreements, ensuring external clinical trial data are in alignment with company Standards and specifications to support data integration, analysis, and reporting.
• Help and advice in setting up infrastructure for external data, to flow into company Clinical data pipelines.
• Responsible for validation of all 3rd Party Data generated in clinical trial into company Clinical Data pipelines.
• Develop strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards and other Study Execution Team members.
• Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
• Representing company in interactions with key external partners as part of company CT3 3rd Party Data Acquisition team.
• Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF.
• Follow procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
• Liaise with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of company.
• Escalate issues to CT3 leadership appropriately.
Qualifications:
Required:
• Serve as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level and manage study start up, conduct and close out activities.
• Create external data transfer agreements, ensuring external clinical trial data are in alignment with company Standards and specifications to support data integration, analysis, and reporting.
• Help and advice in setting up infrastructure for external data, to flow into company Clinical data pipelines.
• Responsible for validation of all 3rd Party Data generated in clinical trial into company Clinical Data pipelines.
• Develop strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards and other Study Execution Team members.
• Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
• Representing company in interactions with key external partners as part of company CT3 3rd Party Data Acquisition team.
• Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF.
• Follow procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
• Liaise with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of company.
• Escalate issues to CT3 leadership appropriately.
• Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
• Experience with all phases of drug development.
• Solid Experience in handling Clinical data acquisition and management from external/3rd Party vendors.
• May lead study level negotiation and agreement for data transfer or integration on behalf of company.
• Should be able to function collaboratively (with some guidance) with all levels of employees, moderate supervision required.
Preferred:
• Knowledge on FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate and Veeva TMF will be a plus.
Company:
Jobdiva Job Portal: https://www1.jobdiva.com/candidates/myjobs/searchjobsdone.jsp?a=xbjdnwgjodtga1y1im2g881fkkeiwd0775lbvq8yqgps8vb2q36w2vj1ga6xxork&compid=-1 Recruitment (contingency search and campus selection). Founded in 2019, the company is headquartered in Arlington, USA, with a team of 201-500 employees. The company is currently Growth Stage.