Archana B

Managed staff in accordance with organization's policies and applicable regulations. Responsibilities include:
• Participated in selection and on boarding process for new staff by conducting candidate review and further interviews.
• Participated in allocation of resources to projects by ensuring assignments are appropriate to staff experience and training; organized staff including shift patterns and number of staff required to meet demand.
• Lead CM Analytics Governance - with responsibilities including resourcing, process improvement, automation initiatives, dual-role training, conducting Gateway program at Portfolio level.
• Provided oversight for execution of training plan, SOP review and mentored training experiences, as applicable.
• Identified quality risks and issues and created appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Performed quality reviews and compliance checks for central monitors on parameters outlined in Quality Oversight Plan.
• Managed feedback/escalation to monitor study deliverables and mitigate risk operationally.
• Conducted monthly connect with individual team members and reviewed performance, quality, compliance to project deliverables.
• Provided constructive feedback for improvement, tracked progress on individual developmental goals.
• Reduced operational risks while organizing data to forecast performance trends.

Oct-2019 till Dec-2021 - CM Analytics Lead provided data analytics solutions and oversight for team of 2 Analytics associates and their respective projects with below responsibilities.

April 2017 till Oct 2019 - Centralized Monitoring Lead for Analytics where I handled projects as an individual contributor with below responsibilities.

Highlights:

• Expertise in Psychiatry and Cardiovascular studies.
• Involved in multiple high volume studies (>15000 randomized subjects).
• Received appreciation from client and senior leadership for successfully implementing data Analytics in high volume study by effectively flagging high risk sites for critical KRIs which was proof point for RBM model.
• In addition to conventional review, I proposed and implemented Predictive analytics, Potential fraud and misconduct analysis for numerous studies which was value add for centralized monitoring approach.
• Established quality review process for data analytics to ensure all analytical reports met standard quality requirements.
• Transformed project data requirements into project data models.
• Ensured team adopted to new in-house built platform for monthly analytics review for their respective projects.
• Coordinated statistical data analysis, design, and information flow.
• Identified and documented detailed business rules and use cases based on requirements analysis.
• Researched and resolved issues regarding integrity of data flow into various databases.
• Performed Knowledge transfer, skills enhancements sessions & prepared future mentors as part of ongoing coaching.

• Developed and planned required basic data analytics scope.
• In collaboration with data owners and functional managers, contributed to development of data analysis methods and procedures for mining study data.
• Performed data trend analysis and data mining in a study based on scope identified.
• Reported trends identified to the attention of relevant stakeholders in study.
• Contributed towards developments of data analysis methodologies and reporting structure.
  

• Identified any anomalies in patient reported data that require further investigation with clinical site to determine overall accuracy with special attention to critical data points such as subject eligibility, IP dosing and compliance, AE & SAE reporting, concomitant medications, protocol required investigations, end of study procedures.
• Reviewed additional information, as necessary, to determine overall readiness of patient information for next level review.
• Reviewed all supplied Line Listings to determine data accuracy across patients within specified group of data points
  
  

• Responsible for Quality Management System of departments’ related to Phase II to Phase IV Clinical Trials and other support departments of Clinigene.
• Involved in preparation, revision, review and distribution of SOPs’ to relevant areas.
• Planned and performed relevant audits: study-based audits (including site audits), quality system audits (based on relevant standards and guidelines applicable), process audits and vendor audits.
• Participated in Sponsor audits and Regulatory Inspections by preparing for audit and liaising with relevant department during preparation.
• Trained personnel in relevant guidelines and regulations.

• Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
• Collected data and followed research protocols, operations manuals and case report form requirements.
• Gathered, processed and shipped lab specimens.
• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
• Resolved CRF queries.