Job Location: Remote
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.
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