PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Senior Clinical Data Analyst
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.
Job Description
Accountability
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 properdocumentation 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.
Candidate Profile : Bachelor’s degree and/or other medical qualifications and relevant industry experience. Certification or involvement in a professional society or organization is recommended.
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.
Additional Information
Location : Bengaluru, Chandigarh, Mohali, Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical
End Date : 20th April 2024
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