Atul Sharma

• Increased customer satisfaction by actively addressing concerns and ensuring timely resolutions.
• Collaborate with Managing Directors on strategic initiatives to drive business growth.
• Streamlined operational processes by identifying inefficiencies and implementing best practices.
• Managing vendor relationships, negotiating contracts for maximum value and efficiency.
• Brought in Automation while minimizing manual processes using technology solutions, increasing accuracy and efficiency within operations.

• Managed and delivered Oncology portfolio with multiple global clinical trials across 3 different programs.
• Led a team of up to 25 associates, supervising their deliveries & performance as well as training and development needs.
• Established strong relationships with cross-functional global clinical trial teams and contributed significantly to the portfolio prioritization and delivered all the assigned projects on time with quality.
• Managed and led multiple cross-functional site/departmental level non clinical initiatives and workstreams.
• Maintained compliance with industry regulations while adapting to changes in the operational processes and best practices.
• Served as Single point of contact for External Relationship Management Team as sub-function lead & represented in areas related to the resourcing, KPIs, KRIs, KQIs for the Outsourced partners.
• Managed and led designated cross-functional non clinical initiatives and strategic site level initiatives
• Served as core member of the Clinical Data Management Hiring team and participated in multiple campus hiring drives as well as lateral hiring to attract key talent.
• Implemented data-driven decision-making strategies, leading to more informed business choices and positive outcomes.

Opened up a tea cafe and had to close after 6 months of operation because of Covid-19

• Led Neuroscience and Ophthalmology portfolio with over 20 clinical trials and managed team size of 15 direct reports.
• Served as primary POC for leading strategic initiative for automation of IVRS 3rd party data transfer to Novartis.
• Led the development of Novartis in-house IRT system by effectively collaborating with Dev IT, Drug Supply Management team, and Randomization Office to manage subject randomization and drug supplies.
• Actively participated in hiring process for Data Management team.
• Mentored my team members, providing guidance on professional development opportunities and career progression paths within the company.
• Conducted workshops within Novartis on critical soft skills including handling crucial conversations and self-management.

• Managed and delivered on Neuroscience Portfolio with over 25 active trials and team of 14 direct reports.
• Managed vendor alliance partnerships with external service provider.
• Maximized performance by monitoring daily activities and mentoring team members.
• Achieved departmental objectives by developing and executing strategic plans and performance metrics.
• Facilitated team brainstorming sessions that led to innovative solutions for long-standing operational challenges.

• Led and managed Multiple Respiratory Studies as a Project and Trial Data Manager.
• Proficiently worked on OC/RDC EDC, Clintrial, JReview applications.
• Independently worked on Study Start-up, Execution and Closeout.
• Independently created study related documents like CRF Completion Guidelines, Data Handling Guidelines, CRF Basis, DB Specs, Validation Modules, DHPs, Data Transfer Specifications.
• Led a team of data management specialists to ensure timely completion of project deliverables.
• Collaborated with cross-functional teams to drive the successful execution of clinical trials.
• Conducted ongoing assessments of data quality throughout the course of each trial, addressing any issues promptly and effectively.
• Assisted in the preparation of regulatory submissions by generating high-quality datasets and relevant documentation.
• Streamlined clinical trial processes for improved efficiency and reduced study timelines.
• Supported the implementation of new technologies and CDMS tools to enhance data management capabilities and streamline workflows.
• Participated in internal audits, demonstrating compliance with industry standards.
• Liaised with external vendors for seamless integration of third-party applications into existing workflows.

• Effectively contributed and supported Trial Data Manager on Study conduct and closeout.
• Extensively worked on Discrepancy Management, Manual Data Review, SAE Reconciliation, 3rd Party Data Reconciliation like Central Lab, ECG, IVRS etc.
• Provided meaningful inputs to Trial Data Manager while creating study specific documents like Data Handling Plan, Data Transfer Specifications, eCRF creation guidelines, Edit Checks Specification document etc.
• Served as a liaison between study teams and external vendors, fostering strong relationships that facilitated seamless communication.
• Assisted Trial Data Manager in database lock activities at the conclusion of trials, ensuring accurate and complete data for final analyses.
• Participated in quality assurance reviews to verify accuracy and reliability of data.
• Enforced strict data validation rules to maintain accuracy and completeness of clinical data.

• Enhanced clinical data quality by implementing stringent data validation processes.
• Recognized as a reliable resource within the team due to my strong analytical skills and dedication to delivering high-quality results.
• Participated actively in regular meetings with sponsors and stakeholders, maintaining clear communication lines throughout projects.
• Expedited study timelines through proactive identification and resolution of data discrepancies.
• Collaborated with cross-functional teams, fostering strong working relationships for seamless project execution.
• Conducted thorough quality control checks on completed datasets, ensuring the highest level of data integrity.

• Increased customer satisfaction by resolving complex issues and providing exceptional service at all times.
• Contributed in designing database in the available CDMS (PheedIt - SAS).
• Contributed towards developing SOP’s as per process requirement and GCDMP guidelines.
• Facilitated the Clinical Data Entry Process.
• Created and Implemented the Project specific Validation Checks.