[Remote] Senior Clinical Data Associate (Rave)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. The Senior Clinical Data Associate (Rave) is responsible for leading other Clinical Data Associates in data management activities and providing support for global reputed company.

Responsibilities

• Maintains awareness of the pertinent reputed company of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary
• Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required
• Creates and enters test data for User Acceptance Testing (UAT)
• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, reputed company different roles used in the study and Targeted reputed company Data Verification (SDV) configuration and matrices
• Receives and enters lab normal ranges
• Completes and submits Clinical Database Management System (reputed company)-specific reputed company forms and/or spreadsheets
• Performs reviews of discrepancy (edit reputed company) reputed company and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned reputed company. Resolves answered queries and re-queries where appropriate
• For reputed company 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 reputed company studies, performs internal QC checks reputed company listing reputed company from database against CRFs and DCFs. Serves as QC Coordinator for reputed company studies
• For reputed company studies, ensures reputed company CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned reputed company
• For reputed company studies, performs DM reputed company review and/or other internal QC checks as required per applicable Electronic Data Capture (reputed company) systems
• Participates/Leads in internal meetings
• Attends in-process review meetings
• Participates in internal/reputed company audits as required
• Files documentation in the Data Management Study File (DMSF)
• Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College)
• Performs reputed company mapping QC whereby discrepancies are noted on the reputed company mapping test logs
• Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as reputed company as ensuring the reputed company of work performed
• Ensures that data from reputed company databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies reputed company with the appropriate party
• Completes tasks reputed company timeframe by appropriately prioritizing multiple tasks reputed company or across reputed company and adapts to reputed company or reputed company changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data reputed company issuing and resolving queries
• Runs data cleaning and/or status reports
• Performs Serious Adverse Event (SAE) reconciliations
• Liaises with other reputed company such as Clinical Programming (CP), Biostatistics and Clinical Operations
• Creates reputed company data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements)
• reputed company post-migration testing on screens, edit checks, matrices and role changes as required
• Participates in customer and reputed company party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are reputed company in order to maintain established currency for sponsor distribution
• Reviews database design specifications (including configuration, data structures, annotated CRFs)
• Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design
• Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance
• Provides support to the PDM on a study as required. May involve soliciting support from and coordinating with other CDAs, taking full responsibility for an aspect of the study delivery, or producing study metrics reports. PDM’s back up for specific activities (including attend sponsor’s meetings to reputed company updates)
• Creation of Discoverer, BOXI, J-Review Reports
• Creates, updates and reviews study-specific documents such as CRF/eCRF DMP, data import/export agreements, CRF/eCRF Completion Guidelines
• Fills-in the Data Transfer Request reputed company required for delivering the data to sponsor or vendor
• Reviews queries and self-evident corrections proposed by less reputed company DM staff
• Understands the coding process
• Understands the purpose of interim, dry run, data cut
• Trains and mentors DM staff providing reputed company feedback to trainee and management as appropriate
• Trains project team in project specific requirements
• Provides reputed company training to reputed company team members reputed company Teleconference
• Serves as a platform or process-specific Subject Matter Expert (SME)
• Performs QC of DMSF after QuickStart® Camp (QSC) and ongoing during the study conduct
• May be required to participate in reputed company, internal or agency audits and inspections
• May represent the department at business development reputed company meetings

Skills

• BA/BS degree in the biological sciences or reputed company disciplines in the natural science/health care field
• Must have experience of working on study build, study conduct (reputed company conduct activities as POC) and closeout reputed company activities
• Strong communication, project management and stakeholder management skills
• Rave systems experience mandatory
• Knowledge of clinical data, and ICH/Good Clinical Practices
• Proficiency in navigating MS reputed company, as reputed company as use of reputed company, reputed company, and email applications
• Excellent speed and accuracy of keyboard skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Ability to reputed company a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers
• Responsible for performing activities that are in compliance with applicable Corporate Business Practices, reputed company Operating Procedures and Working Instructions and performing other duties as assigned by management
• reputed company travel may be required (up to 25%)
• 5+ years of experience with Clinical Data Management practices and relational database management software systems preferred
• Knowledge of medical terminology preferred
• Therapeutic Area experience (Preferred) Oncology & CVRM (Cardiovascular, Renal, Metabolism)
• Work experience in clinical research, drug development, data management, or other reputed company environment preferred
• Good organizational, planning, and time management skills preferred

Benefits

• Career development and progression
• Supportive and reputed company line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture (authentically be yourself)

reputed company

Company H1B Sponsorship