PALAK NIGAM

I took planned time off to focus on family and personal development.

• Spearheaded the maintenance of data for multiple studies, ensuring integrity and accessibility.
• Proactively managed data quality through comprehensive query handling, including query writing, review, closure, and escalation.
• Led the review process and issuance of queries/DCFs for laboratory data, optimizing data quality and reliability.
• Executed self-evident corrections and performed QC on database modifications made by the data management team, enhancing data accuracy.
• Directed the setup of data management study files, facilitating efficient collection, transfer, and archiving of study documentation and controlled documents.
• Maintained meticulous accuracy records of all work conducted, ensuring high standards of data management.
• Proactively built and nurtured relationships with both external and internal team members, fostering a collaborative and effective work environment.
• Led the adoption of advanced data management practices, enhancing process efficiency and ensuring data integrity.
• Key contributor to the establishment and standardization of data management protocols, aligning with regulatory requirements and best practices.
• Maintained data entry guidelines and procedures.
• Therapeutic: Oncology: Solid Tumors (Prostate, Renal)

• Experience in Data Extraction, Cleansing and Data Preparation using SQL and Power BI on both structured and unstructured data based on Big Query, Microsoft Azure Synapse Analytics and Snowflake.
• Built pipelines for data ingestion and data transformation from various source systems databases and files using a combination of SQL, Power BI and on cloud databases like Snowflake.
• Expertise in various Data Analysis tools like Tableau, QlikView, Microsoft Power BI, Excel for complex data modeling, and SQL.
• Worked with variety of data file formats like CSV, TSV, JSON and XML and also with image datasets.
• Effectively Plan and Manage project deliverable with on-site and offshore model and improve the client satisfaction. Experience in attending requirement review meetings and giving feedback to BA and Manager.
• Managed, designed and solution data applications and advanced analytics projects single handedly.
• Good interpersonal skills and problem-solving capabilities and involved in interactions with the client on daily basis.
• Excellent mentoring and team building skills with experience in managing agile project teams and doing Test Driven Development for the projects.
• Ability to work closely across teams (Support, Developer, DM, Solution Architecture) and peers to establish and follow best practices while solving customer problems.
• Led data management efforts, coordinating with Therapy Area Managers to standardize global data management processes, achieving consistency and efficiency.
• Enhanced operational efficiency by initiating a specialized lab group focused on data management, resulting in improved business outcomes and customer interactions.
• Managed comprehensive data management activities, from database cleaning and discrepancy management to vendor relations and data integration, ensuring high data quality and adherence to regulatory standards.
• Streamlined data review and validation processes, significantly reducing time to database lock while maintaining stringent quality standards.
• Fostered collaborative relationships with cross-functional teams, driving successful completion of clinical trial milestones through effective communication and project management skills.

• Developed and implemented SOPs, workflows, and operational guidelines, ensuring GCP and GLP compliance across multiple global clinical trials, including a Phase III cardiovascular study and oncology studies.
• Led data management efforts, coordinating with Therapy Area Managers to standardize global data management processes, achieving consistency and efficiency.
• Enhanced operational efficiency by initiating a specialized lab group focused on data management, resulting in improved business outcomes and customer interactions.
• Managed comprehensive data management activities, from database cleaning and discrepancy management to vendor relations and data integration, ensuring high data quality and adherence to regulatory standards.
• Streamlined data review and validation processes significantly reduce time to database lock while maintaining stringent quality standards.
• Fostered collaborative relationships with cross-functional teams, driving the successful completion of clinical trial milestones through effective communication and project management skills.
• Implemented data analysis protocols to enhance clinical trial reporting efficiency.
• Therapeutic: Oncology and Gastrointestinal.

• Directed project planning and management, ensuring comprehensive scope, goals, deliverables, and timelines with direct sponsor/CRO interaction for oncology studies, emphasizing compliance with ICH-GCP guidelines.
• Led data management operations from start-up through completion, developing Data Management and Quality Management Plans to ensure the delivery of accurate and high-quality clinical data.
• Spearheaded the design and implementation of clinical data models, database designs, and data validation checks, enhancing data review and discrepancy management processes.
• Coordinated cross-functional team efforts and vendor reconciliations, managing project budgets and promoting effective collaboration to achieve quality data delivery within timelines and budget.
• Therapeutic Areas: Oncology & Cardiovascular

• Interned in a trainee position, actively engaging in data management tasks such as query resolution, data reconciliation, and integrity assurance.
• As a trainee, supported clinical operations by monitoring study progress, ensuring adherence to protocols, and maintaining effective communication.
• Played a crucial role during my internship as a trainee, overseeing site compliance and fostering stakeholder engagement for successful trial outcomes.

• Conducted comprehensive examinations to accurately diagnose oral health conditions and meticulously develop personalized treatment plans tailored to meet the unique needs of each patient.
• Provided education on essential oral hygiene practices and recommend preventive care strategies, including fluoride treatments and dental sealants, to effectively maintain optimal oral health.
• Skillfully performed a variety of restorative procedures, such as fillings, crowns, and bridges, to address and treat cavities and decay, all the while ensuring the utmost patient comfort and satisfaction.
• Executed complex surgical procedures, including extractions and root canal treatments, with a steadfast commitment to adhering to the highest standards of safety and sterilization protocols to ensure patient’s well-being.
• Efficiently managed patient appointments and meticulously maintain records, fostering effective communication and seamless collaboration with dental staff to ensure smooth and efficient clinic operations.