Job title: Senior Clinical Data Analyst

Company: Parexel

Job description: Job Purpose: The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and aut

Job Purpose: The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. Further responsibilities shall include providing technical expertise and/or operational leadership regarding all DM operational activities (data cleaning matrices), processes and Data Management documents regarding data validation. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements. SCDA acts as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors. The SCDA may act as a back-up to or fulfill the Data Management Lead role where required. Key Accountabilities: Data Validation (cleaning) . Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g. query management, manual/SAS listing reviews and external vendor data reconciliation. . Highlight issues/risks to delivery by understanding interdependencies – support mitigations as part of Risk Management Plan Data Management Documents/Plans (Trial Master File) . Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines. Study Start-Up Activities and User Acceptance Testing (UAT) . Lead/perform user acceptance testing on clinical database setups. . Review protocols and EDC Entry Screens if required. . Provide input on and tracking the data management timelines and coordinate the DM operational activities during database set up, up to project close out. Data Tracking and Entry . Track and review CRFs. Support data entry where required. Project Quality Management & Compliance . Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines. . Perform/Lead functional QC activities on databases and/or patient data, as per business needs. Training . Maintain training compliance as per Job Roles assigned, including On-the-Job training. . Address training needs, as per Development Goal/s identified. . Provide relevant on-the-job training to staff and project teams as appropriate . Act as Mentor for other clinical data analysts. . Act as Subject Matter Expert regarding DM operational tasks/tools/ processes/ systems. Process/Project Improvement . Develop, improve and implement project specific tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies. Project Finance & Resource Support . Determine root cause of operations-related project variance in a timely manner, based on DM operational metrics/labor hour reports – provide input on Changes in Scope needed. Skills : . Proven ability to lead and collaborate with global and cross-functional teams – ability to coordinate & prioritize tasks for the DM operational and programming teams (when) in the Primary CDA role. . Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed. . Proven negotiation skills and ability to influence in order to achieve mutually beneficial results. . Strong problem-solving skills and logical reasoning, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses. . Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail). . Proven Time management and prioritization skills with a strong sense of urgency – in order to meet objectives. . Advanced interpersonal, oral and written communication skills – using concise phrasing tailored for the audience with a diplomatic approach. . Good presentation skills. . Proven learning ability and knowledge sharing approach swift understanding of technologies and new processes. . A flexible attitude with respect to work assignments and new learning ability to adjust rapidly to changing technical environments. . Strong sense of accountability relative to Key Accountabilities in Job Description. . Innovative – ability to define strategies to improve efficiency when performing the Data Management tasks. . Written and oral fluency in English. Knowledge and Experience: . Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills). . Advanced understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock). . Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures. . Advanced knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, DataLabs, ClinBase.) . Good understanding of Clinical Study Team roles within Data Management – awareness of DML activities e.g.: budget reviews, resource forecast, etc. . Experience in clinical research industry. . Advanced knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG). . Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out. . Advanced knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation. . Basic knowledge of SAS (programmed listings). . Basic knowledge of Data standards (CDISC). . Good understanding of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work. . Proven experience of leading virtual/global Data Management operational team/s to perform DB set up, data cleaning activities. Education: . Bachelor’s degree and / or other medical qualifications or relevant industry experience. . Certification or involvement in a professional society or organization is recommended. #LI-REMOTE

Expected salary:

Location: India

Job date: Thu, 25 Aug 2022 22:40:34 GMT

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