Sangam Leeladhar Naik

As an Assistant Clinical Project Manager II, my key responsibilities included:

• Project Administration:
  Drafting project documents and reviewing/editing presentations.
  Participated in project meetings, conference calls, and training sessions.
  Developed a thorough understanding of project protocol documents.
• Project Monitoring and Communication:
  Monitored internal data flow to ensure timely task completion.
  Responded professionally to inquiries and maintained client communications regarding project status.
  Verified adherence to protocol imaging requirements and addressed site/sponsor queries appropriately.
• Financial and Reporting Support:
  Assisted with project finance activities, including documentation updates due to scope changes and billing.
  Followed up on invoice reconciliations.
  Prepared project reports to support forecasting activities.
• Team Support and Process Improvement:
  Mentored and supported the Operations team, providing feedback to cross-functional leads.
  Participated in process improvement initiatives and recommended operational procedure enhancements. Mentoring/Training Assistant Clinical Project Managers.
• Client and Stakeholder Engagement:
  Served as a point of contact for clients, sites, and sponsors, ensuring timely project delivery.
  Assisted in tracking and resolving client issues.
  Supported logistics related to the distribution and management of site-facing materials.

These responsibilities contributed to the successful initiation, execution, and closeout of projects, ensuring compliance with regulatory standards and project timelines.

I have successfully managed individual studies from initiation through execution, ensuring adherence to timelines, budgets, and regulatory standards. This involved developing detailed project plans, coordinating cross-functional teams, and maintaining effective communication with all stakeholders to achieve project objectives.

As an Assistant Clinical Project Manager, my responsibilities encompassed a range of tasks aimed at ensuring the smooth execution of Projects

• Project Administration: Drafting and editing project documents and presentations.
• Meetings and Training: Actively participated in project meetings, conference calls, and training sessions to ensure a thorough understanding of project protocols.
• Project Monitoring: Maintained and communicated project progress by monitoring internal data flow, ensuring tasks were completed within agreed-upon timeframes.
• Client Communication: Responded promptly and professionally to inquiries, maintained regular communication with clients regarding project status, and diligently followed up on outstanding items such as missing data and incomplete paperwork.
• Issue Resolution: Played a key role in tracking and resolving client issues, escalating concerns as necessary, and served as an additional point of contact for clients, sites, and sponsors to support timely project delivery.
• Compliance and Quality Assurance: Upholding quality service and departmental standards by adhering to organizational Standard Operating Procedures (SOPs) and executing technical and clinical functions in compliance with company Good Clinical Practices (GCP), International Council for Harmonisation (ICH), and FDA guidelines.
• Process Improvement: Contributed to the modification of company SOPs and participated in relevant training sessions to maintain and enhance technical knowledge.

As an Imaging Research Associate (IRA), my key responsibilities included:

• Site Coordination: Managed site activities from study initiation to closeout, ensuring timely delivery of high-quality service deliverables.
• Documentation Management: Followed up with clinical sites to obtain necessary documentation for site qualification.
• Data Discrepancy Resolution: Assisted in monitoring and resolving data discrepancies identified by the clinical data management team.
• Communication Management: Oversaw communications with clinical sites, generated and verified site and patient reports, and addressed queries prior to distribution to stakeholders.
• Quality Control: Performed daily Internal Quality Control (IQC) activities, including coordinating, tracking, and processing IQC data.
• Stakeholder Communication: Maintained effective communication with the clinical study team and sponsors regarding deliverables to meet project timelines.
• Project Tracking: Reviewed and analyzed project tracking, generating weekly and monthly reports, and followed up on outstanding items such as missing data and incomplete paperwork.
• Client Issue Resolution: Assisted in tracking and resolving client issues, scheduling, and monitoring the completion of site training sessions.
• Training Participation: Actively participated in project meetings, conference calls, and training sessions to ensure adherence to project timelines and successful execution of clinical trials.
  
  These responsibilities contributed to the effective management and execution of clinical research studies, ensuring compliance with regulatory standards and fostering collaboration among stakeholders.

As an Associate Clinical Data Coordinator, my key responsibilities included:

• Clinical Data Analysis: Conducted thorough analyses of clinical data to ensure accuracy and quality reporting.
• eCRF Review: Reviewed electronic Case Report Forms (eCRFs) to verify data integrity and compliance with study protocols.
• Data Status Reporting: Prepared comprehensive Data Status Reports to monitor and communicate data progression to stakeholders.
• Sponsor-Vendor Reconciliation: Engaged in reconciliations between sponsors and vendors to ensure data consistency and resolve discrepancies.
• Data Validation and Query Management: Performed data validation checks, managed queries, and ensured timely resolution to maintain data accuracy.
• Quality Control: Implemented quality control measures to uphold high standards in data management processes.
• System Proficiency: Utilized Advanced Distribution Management System (ADMS) and NON-ADMS platforms for effective data management.
• Study Documentation: Prepared and contributed to study-related correspondence, including Data Status Reports and tracking spreadsheets, to facilitate effective communication among stakeholders.
• Software Expertise: Applied knowledge of Oracle Inform 5.5, Inform 6.1, and Medidata RAVE to perform data entry, execute manual and logical checks, conduct database testing, and perform visual verification.
• Team Collaboration: Participated in weekly team meetings to discuss project progress, develop improved plans, and revise protocols to align with project objectives.
  
  These responsibilities have equipped me with a comprehensive understanding of clinical data management, emphasizing accuracy, quality, and effective communication to support the successful execution of clinical research studies