Mariya Malekar

About Mariya Malekar

Serving as ACDM on assigned projectsManaging end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Providing comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Providing leadership to the team in the areas of project planning, execution, and close-out; EAC forecasting; communications; and milestone deliverables. Performing role of back up Data Team Lead (DTL). Complying with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.Serving as Data operations coordinator on data management deliverables. With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise. Maintain strong customer relationships. Ensure open communications with customer and IQVIA management to manage and meet contractual obligations.Meet with team members on a regular basis to ensure milestones meet timelines and quality deliverables. Establish strong communications with Data Operations team, functional leads, project managers and all other stakeholders. With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects.With guidance, working with client data managers, vendors, internal team members for resolution. Continuously looking for opportunities to improve efficiency of tasks and quality of deliverables and identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution. Identify out of scope tasks and highlight to DTL. Performing SAE reconciliationsProviding study metrics to the team and highlighting outstanding issues and following-up until resolutionMentoring and training CDCsPerforming Validation of reports and Listings/ Writing test plansPerforming data review, writing and resolving data clarifications

Experience

1. Associate Clinical Data Manager

   Fortrea

   Aug 2025 — Present · IN

Education

• Cranfield University

  Msc, Clinical Research Coordinator

  2010 — 2012

• Kristu Jayanti University

  Bsc, Biotechnology

• Presentation Convent High School

  Standard Tenth

Skills

• Data Analysis
• Data Entry
• Gmp
• Research
• English
• Microsoft Office
• Clinical Research
• Teamwork
• Validation
• Windows
• Public Speaking
• Microsoft Excel
• Powerpoint
• Laboratory
• Life Sciences
• Social Media
• Microsoft Word