Senior Clinical Data Analyst

1 month ago

Bengaluru, Karnataka, India Parexel Full time

About the Role

The Senior Clinical Data Analyst will 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.

Key Responsibilities

  • Provide technical expertise and/or operational leadership regarding all DM operational activities (data cleaning matrices), processes and Data Management documents regarding data validation.
  • Act as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors.
  • 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.
  • Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.
  • 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.
  • Track and review CRFs. Support data entry where required.
  • Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
  • Perform/Lead functional QC activities on databases and/or patient data, as per business needs.
  • 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.
  • 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.
  • 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.

Requirements

  • 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.

Preferred Qualifications

  • 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.

Location

Bengaluru/Hyderabad/Mumbai/Mohali

Education

Bachelor's degree and/or other medical qualifications and relevant industry experience.

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