PROFESSIONAL SUMMARY:

• Oncology Project Data Manager with 8.5 years of Clinical Data Management expertise and with 3 years of experience as a professor. Total working experience of 11.5years.
• Worked as International Trial Data Manager and Project Data Manager on a number of Oncology trials. The responsibilities includes coordinating Trail Data Management activities within the Data Management teams, interacting with Clinical, Database Development, Programming, Statistical groups and other global counterparts regularly to ensure the completeness and accuracy of clinical data is meet. Worked on RDC (Remote Data Capture), EDC (Electronic Data Capture) and Paper based studies. As a Project Data Manager worked on several pivotal and registered trials responsible for ensuring that project key deliverables are met in time, at a high quality and within budget. Member of the international study group, plan and conduct team meetings, International Clinical Trial meetings (ICT), Clinical Trial meetings (CTT), Data Review Team meetings (DRT) with focus on information sharing, stakeholder engagement and decision making. This includes vendor management and participating in the trial execution. Contribute to and participate in investigator and monitor meetings. The job involves applying a structured and analytical approach during development of relevant trial documents such as trial protocol, informed consent, recruitment strategies, risk analysis plans, communication plans and trial budgets. Fulfill the role authority and accountability to effective managed the conduct of all studies within a program. Acts as the initial advising resource for trial and supporting data managers for study specific issues. Worked on multiple trails under the below indications in Oncology: Renal Cell Carcinoma Hepatic Cell Carcinoma Neuroendocrine Tumors Lymphoma - Diffuse Large B Cell Lymphoma Breast Cancer.
• Currently on H1 with VSoft Infoware. Intend to work with organization related to Clinical Research,Drug Developmentwhich will help me to explore myself with all expertise. Willing to work as a key player in challenging and creative environment.
• Project management authority
• Effective staff coach
• Talented interviewer
• Strategic planning capability
• Planning and development
• Analytical thinker
• Accomplished leader
• Independent judgment and decision making
• Promotes positive behavior
• Budgeting proficiency
• Strong presentation skills
• Strong experience in Electronic Data Capture software(s) likeApplication Framework, Oracle Clinical, Integrated Review, J Review, Clintrial - CT4 database
• GRT-General Reporting Tool, SQL
• Experience in E-Clinical
• Experience in RAVE, Inform
• Worked on Network operations like Citrix Metaframe server, VPN connectivity, WDCS Process specific reporting tools (Web based Database Communication Systems)
• Excellent Experience in MS Office - Word, PowerPoint, Excel, MS access, Outlook, Lotus Notes, Acrobat

PROFESSIONAL EXPERIENCE:

Project Data Manager and Trial Data Manager

Confidential

Responsibilities:

• Fulfill the role authority and accountability to effective managed the conduct of all studies within a Program.Ensure the data management needs are met from a Global Data Management perspective.
• Facilitate communication between the International Clinical Team (ICT) and Clinical Study Team (CTT).
• Proactively identify issues that threaten study or project success and drive the implementation of solutions.
• Extensively worked on several reconciliation activities like SAE, Central lab, local lab, Imaging, Biomarkers, IVRS, PK, and Archival Tumor data. Subject Matter Expertise on SAE, local lab and third party data reconciliations.
• Developed several reports/listings specifications for data cleaning purposes, example missing pages report, customized query report, and customized data cleaning reports for reconciliations. Developed Manual Data Review guidelines to enhance the quality of data for reviews not managed through programming.
• Proposed and developed edit specifications as per study specific and project specific need.
• Expertise onproposingsolutions for protocol amendment activities.
• Represents Data Management on the ICT and is responsible for communicating project level decisions and agreed conventions to all CTTs within the project.
• Direct communication with Trial Data Manager, Line Manager, and cross functional partner groups (e.g., Stats Programming, Stats, Clinical, Drug Safety & Epidemiology) to create a team approach to issues that may have an impact on a program’s success.
• Provided consistent Data Management (DM) leadership for all trial phases from planning, to execution, through CSR generation.
• Performed Blinded Data Quality to ensure that errors in the database are addressed by the data cleaning processes documented in the Data Management Plan, to identify any unusual or unexpected trends in the data, followed process of reviewing all data to optimally support the programming of the CSR outputs.
• Provided data management related s to CRAs on any gaps in the site understanding of the protocol. Develop eCCGs(e-CRF Completion Guidelines)and circulate to the CTT.
• Acts as the initial advising resource for Trial or supporting data managers for study specific issues.
• Specific responsibilities when reviewingthe following documents for quality: Protocol, Data Handling Plan/Validation Analysis Plan (or equivalent), Data Review Plan, Study Specification Document, Database Deliverables, Project level data handling conventions.
• Ensure consistency of protocols, VAPs/DHP/SSD & Project CRFs, data transfer specs for all trials within assigned project(s).
• Review and ensure TDM follow-up on outstanding issues from Blinded Interim Quality Reviews and Dry Runs.Advocate for creation of project level documents: Protocol Deviation codes, Standard Edits, Data Transfer Specification for third party data, Reconciliation guidelines and standard listing review of issues.
• Ensure studies have implemented the available efficacy related programmed reports/listings.
• Participate/facilitate Data Base Lock and other snapshot timelines discussions and ensures team alignment for both, Final DBL and Interim Analysis deliverables.
• Review and provide feedback on Task Order Agreements, Vendor BIDs and SSWs for Outsourced studies.
• Proactively identify and address backlogs and potential bottle-neck activities, coordinate work flow to ensure all studies are adequately resourced, escalate project needs as appropriate; continuously monitors workload of TDMs and ADMs and allocates resources as needed to address upcoming deliverables.
• Develop risk management strategies to proactively prevent data quality issues.
• Refine requirements for data validation based on metrics and lessons learned from data cleaning activities to date.
• Ensure ICT metrics/tracking information is accurate and up-to-date.
• Trained and coached on average of 5 new employees per year.

Data Validation Team Lead

Confidential

Responsibilities:

• Managed a group of 11 data validation associates and was the primary interface with the on-shore team and client. Excelled as value creator, people developer and business operator.
• Worked with Contract Research Organizations (CROs), expertly gathering and analyzing data for highly confidential clinical trials.
• Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the data-management lifecycle.
• Advanced skills in EDC systems, expert in database design and study conduct, well-versed in GCP and FDA standards and regulations, and knowledgeable in therapeutic indications.
• Identified issues, propose suitable resolution, and work towards improving the overall process of providing study status updates, improving reporting to the satisfaction of study team.
• Minimize unwanted tracking and reporting. Identified and worked to eradicate rework and wasted efforts, trained and coached team members. Knowledge sharing with data managers on how validations/edit checks are designed. Studies assigned to be managed well from start to lock/freeze of study. Tracked Study Level Agreements, dates and provide updates.
• Used Work Allocation process to optimize resource utilization. Ensured clinical team reviews data on an ongoing basis to meet the timelines and follow up accordingly. Worked on any issues related to validations and proposed solutions. Measure the quality of the team. SQL scripts experience to derive the data and check for any updates, modifications needed accordingly; also to provide the data at country, site and Investigator level to the Global Trial Managers and Regional Site Monitors.
• Ensured the completeness and validity of the clinical trial data that has gone through data entry. Reviewed and resolved discrepancies identified by the system or through manual checks as per guidelines. Issued data clarification forms as and when required.
• Track, review and close all DCF responses received. Generate and review CRF summary report and track missing CRFs. Review and address all clinical data review issues. Review and validate bio-analytic data. Provide expert comments and feedback on quality initiatives like Data Processing skill center. Interact with the client regarding data quality issues. Ensure timelines set by client in terms of production and clean patient delivery. Mentor data managers to perform editing until they are certified. Generate, analyze data and prepare study related reports in MS Excel when required.
• Worked as a Project Lead forhigh Priority studies which successfully met the QI. Regular interaction between onshore lab team and offshore team.