Crf jobs

A Voice BPO job typically involves handling customer interactions over the phone addressing inquiries resolving complaints and providing customer support. This includes tasks like verifying aA Voice BPO job typically involves handling customer interactions over the phone addressing...

 ...information source Ongoing training for project teams in therapeutic areas as requested Review of study documentation (protocol, CRF. etc.) Contribute to investigator meeting presentations Ongoing safety review of individual patient laboratory reports generated by... 

 ...trends. Manages data management issues by reviewing protocols for cross-project consistency and identifying standard Case Report Form (CRF) modules to meet objectives. Develops data quality plans. Provide early strategic input into protocol design focused on data... 

 ...in computer science, information technology, life sciences, or a related field. ~3 + years of experience in Clinical System design (CRF design and Rave) ~ Experience in system design and implementation, preferably within a clinical research environment. ~ Strong understanding... 

 ...deliverables meet quality and timelines within approved scope ~ Provides study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management ~ Define specifications and collaborate with technical team on... 

 ...with SDTM. Extensive programming experience in Base SAS, Advance SAS. Minimum 8 year of end to end to SDTM Programming experience -CRF annotation, Specification generation, dataset creation, submission package, Pinnacle 21 review, SDRG. Must have experience trial design... 

 ...Associate, Indexing Associate, or other role as defined by manager. Process, log, and track clinical study documents in accordance with CRF Tracking and Data Entry Guidelines. Process and enter data accurately and in a timely manner in accordance with CRF Tracking and Data... 

 ...management departmental training related to technical processes and systems Other project specific training Supports the development of CRF and eCRF completion guidelines Supports the development and review of specifications for listings and summaries (other than for... 

 ...Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary,... 

 ...and approve analysis dataset specifications. Review and approve key study-related documents produced by other functions, e.g., SAPs, CRF, Data Management Plan. Write, test, validate, and implement department-, product-, and protocol-level macros and utilities. Lead... 

 ...layer/ and comply with the Governance Committee strategy. Have hands-on experience with various clinical datasets such as EDC and non-crf dat combined with strong analytical abilities capable of managing diverse, large, and complex datasets, which ranges from fundamental... 

3 to 5 years of experience in CRF systems, HVAC, and AHU Split AC units. Strong knowledge of air conditioning systems installation, maintenance, and troubleshooting. Ability to diagnose and repair mechanical and electrical faults in AC systems. Familiarity with... 

 ...and approve analysis dataset specifications Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc. Write, test and validate software programs in Unix to produce analysis datasets and presentation output,... 

 ...rules. Provide programming feedback to Statisticians and align on shells. Build SDTM from raw sources with end-to-end traceability to CRF and EDC exports. Perform precise SDTM CRF annotation aligned to CDISC SDTM IG and trial design domains. Apply controlled... 

 ...studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves... 

 ...required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and... 

 ...Resolution and problem solving skills. Agile, waterfall, hybrid and other methodologies. CRO / Pharma / Regulatory (including 21 CRF Part 11, SOX) experience an advantage Benefits of Working in ICON: Our success depends on the knowledge, capabilities and quality... 

 .... Course & Faculty Coordination 35% KRAs: Preparation of personalized schedules for teaching faculty. Course coordination and CRF (Course Requirement Form) preparation. Course pack compilation. Coordination with IT/AV, ITCS, LRC, and Central Printer. KPIs:... 

 ...lab reports and update PI Ø Review & implement appropriate recruitment/referral activities for active enrolment at sites Ø Ensure CRF Completion and query resolution on specified timelines Ø Coordinate in conduct of monitoring visits and audits (Internal or External... 

 ...and the utilization of ICON/client specific standards. Good functional knowledge of at least one clinical data management system and CRF design tool. Ability to plan and design CDMS components directly from interpretation of low to medium complexity clinical trial... 

 ...internal company standards of the corresponding CRFs, timing of assessments, implicit assessments (e.g. fed conditions require food intake CRF), Adverse Event definitions versus CDASH, validated questionnaires, laboratory data, etc. Advise other Biometrics functions, Project... 

 ...Report Forms (CRFs) and Data Management Plans (DMPs) Manage clinical trial data from study start-up through database lock, including CRF tracking, query resolution, and database maintenance Ensure accurate and timely entry, review, and cleaning of clinical data in accordance... 

 ...comments to statistical analysis plans and analysis output. Reviews and provides epidemiology input for scientific tasks including CRF/eCRF development form previews data mapping and integration and other ad hoc project tasks (e.g. regulatory responses slide deck development... 

 ...study results and preparation of statistical methods section for clinical/statistical reports; Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis; and Communicate statistical... 

 ...Perform PPM launch related activities in co-ordination with NMP & Program team to ensure timely system set-ups. Track all new PDL's / CRF's / TIBs in region and drive team to ensure MP&L / PPM timings are supportable. Represent PPM in PST meetings, Regional BOM and... 

 ...Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.) Co-leads the design & development for these solutions from a business view Co-leads... 

 ...study results and preparation of statistical methods section for clinical/statistical reports; Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis; and Communicate statistical... 

 ...supervision Support maintenance of Trial Master File (TMF) and essential documents Assist in source data verification (SDV) and CRF review Coordinate with site staff for study-related activities Ensure compliance with ICH-GCP, SOPs, and study protocols... 

 ...testing, and system integrations. The Clinical Study Builder will work principally on Rave CDMS, but might also be requested to build CRF using different EDC systems, like Medrio or Veeva. In addition, this position is required to conduct all these activities in conformance... 

 ...customer requirements. Essential Functions Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF database design and set-up validation definition and programming Data Management Plan and database deliverables to internal and...