Ranjitha Masna

Senior Clinical Data Manager

Summary of skills:

Hands on experience in various phases of clinical trials and drug development.

Experienced in Clinical Data Management and programming in Pharmaceutical/CRO environment mainly including analysis using SAS.

Good knowledge and hands on experience in Clinical Database development and Programming using various EDC tools and systems. Vendor management.

Worked for all phases for Oncology trials

Understanding of Data Models and implementation for database development

Strong knowledge of SQL, PL/SQL, SAS to develop edit check programming

Contributed in the development and maintenance of project specific libraries as per the CDASH standards

Effective working relationship with Cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), eg: as member of the clinical trial team

Study level expertise and involvement in CTTs and on GPTs for the projects

Create, maintain, provide data transfer specifications (DTS) for third party data to the vendors.

Subject Matter Expert in functional and technical processes and systems

Participated in the review of Clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical analysis).

Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements

Coach and mentor new associates in CDM and related processes and CRO/Vendor Management.

Study planning to ensure timely commencement of CDM Deliverables with Quality, Project Management.

Onsite experience – Travelled twice to Basel on Business requirement for training the vendors/CROs

On Boarded new Vendor – involved in all steps from selecting the vendors, interviewing, budgeting to on boarding.

Trained the CRO (ClinTec) on the Novartis processes, conducted class room trainings by travelling to their site.

Review/create Standard operation procedures, guidelines, business guidance etc.

Vendor management Oversight, resource planning.

Represented the team in global cross functional meetings, Knowledge exchange and experience in leading global meetings.

Work Experience

Novartis Healthcare 04/2014 and 06/2017

Senior Clinical Data Manager

Roles & Responsibilities:

Responsible for creation of DMP (Data Management Plan, Data Entry Guidelines, CRF Completion Guidelines, Case Report Forms) and Edit Checks Specifications, Edit Checks Testing and Validation for studies such as UAT, Reports, Review and Validation. Data Cleaning/Discrepancy Management of projects according to the SOPs to ensure compliance with the study protocol. Support of the documentation, testing, implementation, validation, and utilization of systems used in Clinical Data Management activities.

Performed data management (DM) activities for the assigned clinical trials studies ensuring (CDM) procedures and processes to meet business requirements. e.g. (Performed as a lead to two complex studies: CRF tracking, reviewing, query generation, resolving data clarification forms (DCFs) and a direct contact person globally).

Lead data management activities from protocol review, through CRF and Database design, trial conduct, and database lock. Define and refinement of departmental procedures and standards, all in accordance with GCP and SOPs

CRO Oversight and Management: Oversee alignment of Data Management (DM) activities with project standards for outsourced trials in accordance with the contracts agreed with the multiple vendors. Follow up and resolve issues and escalate to management as needed.

Develop and maintain trial specific database applications, including eCRFs and database specifications, program validation and derivation procedures within the clinical database management (such as OC/RDC, Inform, Rave) using relevant programming languages (SQL, PL/SQL, SAS) system in support of in-house and outsourced trials globally, of various levels of complexity for Phase I-IV independently or with minimal supervision.

Good knowledge of Clinical Data Standards e.g. SDTM. Understanding of Data Models and implementation for database development

Develop the eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries.

Create, test and maintain trial specific plausibility and consistency checks.

Provide data transfer specifications for third party data.

Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes.

Develop database specifications and provide support for outsourced trials.

Create, file and maintain appropriate trial documentation.

Program and test procedures, of various levels of complexity, according to documented trial specific requirements, within the clinical database management system using relevant SQL, PL/SQL, SAS

Maintain and update procedures as required for protocol amendments or required post production changes.

Creation and Execution of trial design reports based on trial metadata.

Good knowledge of Novartis Clinical Data Standards. Understanding of Data Models and implementation for database development.

Act as a trainer/mentor to new or less experienced associates on specific task(s).

Contribute in the development and maintenance of project specific libraries.

Co-ordinate activities of all programmers either internally or externally (FSP, CRO) assigned to the study/studies. Make Statistical programming recommendations at study level.

Build and maintain effective working relationship with Cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), eg: as member of the clinical trial team.

Review eCRF, Discuss data structures and review activities as member of the data review team.

Extensive working experience with Data collection, Data management and Report tools in pharmaceutical industry

Good Knowledge of Clinical Trial Management System & phases of clinical trial.

Knowledge on creation of annotated CRF.

Comply with company, department and CDISC standards and processes, review and develop programming specifications as part of the analysis plans.

Provide input into statistical programming solutions and/or ensure their efficient implementation.

Ensure timely and quality development and validation of datasets and outputs for CSR, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to the specifications.

Responsible for quality control and audit readiness of all assigned deliverables as well as accuracy and reliability of Statistical analysis results.

Good understanding of regulatory requirements relevant to statistical programming GCP, ICH, procedures and methodologies.

Novartis Healthcare 04/2012 - 04/2014

Clinical Database Developer & CDM

Roles & Responsibilities:

Develop Data Management Plan (DMP), Setup and maintain database. Process data and assist in trial site management. Perform quality checks and database lock

Provide timely and professional ongoing management of project and clinical trial by developing and maintaining trial specific database applications, including eCRFs and database specifications, program validation and derivation procedures of various levels of complexity within the clinical database management system in support of in-house and outsourced trials globally for Phase I-IV independently or with minimal supervision.

Support or lead a special project of limited scope (sub-team lead, local project, etc.) both clinical and non-clinical in nature. Provide study level expertise and involvement in CTTs and on GPTs for small projects.

Contribute to the review of global SOPs and business guidances directly impacting the function and providing input when applicable

Develop the eCRF layout and corresponding database according to documented trial specific requirements, using components from existing libraries

Create, test and maintain trial specific plausibility and consistency checks

Provide data transfer specifications for third party data

Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes

Develop database specifications, provide guidelines for db setup, review externally created documents, and interact with external partners for outsourced trials

Create, file, and maintain appropriate trial documentation

Program and test complex procedures, according to documented trial specific requirements, within the clinical database management system using SQL or PL/SQL

Maintain and update procedures as required for protocol amendments or required post production changes and ensure project level consistency

Creation & execution of trial design reports based on trial and project metadata

Demonstrated experience in the concepts and use of Clinical Data Standards (e.g. SDTM, Novartis standard) preferrred. Understanding of Data Models and implementation for database development

Supervise the work of less experienced associates.

Act as a trainer to new or less experienced associates on specific task(s)

Lead in the development and maintenance of project specific libraries for small projects within in their function

Subject Matter Expert in functional and technical process and systems

Serve as Project DB Developer for projects.

Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.

Reconcile electronic data transfers from vendor to Sponsor. • Develop test scripts and execution logs for User Acceptance Testing (UAT).

Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.

Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.

Perform training on study trial for EDC and create user guides. Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation.

Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit. • Coordinate the archiving of study databases and related documents.

Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs. • Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.

Assist and provide input into study and project level data analysis plan. • Coordinate and communicate with DB vendors on consistent basis to address Clinical teams requests, project plans, and/or eCRF development activites.

Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.

Participates in the preparation and presentation of data, when applicable. • Ensures data system compliance by following the established guidelines of national and international regulatory authorities. Participate in conference calls and/or meetings with vendors.

Novartis Healthcare 04/2010 - 04/2012

Clinical Data Manager

Roles & Responsibilities:

Coordinate CRF design as per established standards and applicable protocol.

Build, test and validate clinical database.

Develop and execute SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance.

Document, verify, validate and execute regulatory compliant programs to perform clinical data management activities.

Engage in study planning to ensure timely commencement of CRF and database design and edit checks.

Guide teams to capture data using methods such as Electronic Data Capture.

Guarantee that user acceptance testing, data transfer requirements and deployment of clinical trial sites are well defined.

Develop requirements of edit checks to guarantee high data quality and develop reports.

Coordinate with clinical research and database analysts in clinical trial databases’ design, development, testing and documentation.

Develop, code and test non-complex data management work products such as data entry screens and database tables.

Manage and track CRF flow and scanning and input required data.

Use problem solving and judgment to apply Clinical Data Management principles.

Update new technology developments and comply with clinical data management associated regulatory issues.

Enter and compile data to generate and develop summary reports and graphics.

CRF design and coordination activities for all trials, including vendor management, review of cost estimates and invoices. Maintaining the CRF planning Database, Standard CRFs, Provide inputs/comments to the SOPs and CRF related forms. Coordinating PROs/Diaries for all the trials (inhouse/outsourced). Create manuals/ trained vendors and in house designers.

Handle the complete unit including the multiple global vendors and internal group.

productivity and quality.

Coach and mentor new associates in CRF and related processes.

Provide Clinical data management support to Clinical Operations team and/or study project, Clinical Data Management team and Biostatistics team.

Participates in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).

Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.

Novartis Healthcare 04/2008- 04/2010

CRF Designer and Coordinator

Roles & Responsibilities:

Produce Case Report Forms for all Clinical Phase I-IV studies. This includes reviewing study protocols, drafting CRFs, ensure adherence to SOPs and global and TA-specific CRF standards, providing constructive feedback to clinical team.

The CRF designer will use existing software to perform all tasks and produce a final CRF book for use by a printing facility

In support of trials and problems of low to moderate complexity and with supervision while adhering to all relevant GCP guidelines and departmental NIPs/SOPs

Create all CRFs for a given study based on standard rules & guidelines. Ensure global consistency by developing the CRFs using the standard naming conventions and the existing library of global / TA-specific standard CRFs.

Many forms will have to be created from scratch and entered in to the global central CRF library.

Interpret from protocol summary and protocol, the pertinent medical/scientific data that will comprise the CRFs employed in clinical trials.

Work closely with Data Management and clinical team to determine timeframes and gather input into CRF design, to achieve a timely approval.

Actively participate in CAPA and CRF review meetings to discuss the CRFs for a clinical project and offer suggestions regarding pCRF format and data collection requirements.

In addition, make changes to CRFs based on decisions from the clinical team and ensure that requests for approvals are filed for deviations from standards.

Distribute the revised CRFs appropriately.

Prepare print/shipment specifications and ensure proper procedures are followed for CRF books.

Develop Case Report Form (CRF), electronic and/or paper.

Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.

Biotrail Pvt Ltd. 12/2005 to 04/2008

Clinical Data Associate & Programmer Analyst

Roles & Responsibilities:

Working with the Project Manager (PM) and CDM members to establish and adhere to timelines for all CDM activities for assigned projects

Reviewing and approving data management plan components (Study summary/data flow diagrams, Timelines, Critical Variables list, etc).

Reviewing data validation specifications and Coordinating input in protocol preparation.

Handling AE/SAE reconciliation.

Defining data entry conventions.

Defining edit checks for data cleaning

Generate queries on clinical data (raising DCF) to be sent to clinical sites for resolution.

Clean database by generating data queries, performing QC of data, reviewing data listings, etc.

Work with the PM and a CDM Study Management Team member to ensure quality built into the deliverables.

Doing SAS programming for pharmaceutical clinical trial data reading, import and data analysis.

Statistical software: Excellent Skill in: SAS-9.1.3, SPSS-14, STATA, SQL, and MACRO

Provide proper validation, including testing and documentation (e.g., requirements document, program validation), in accordance with company standards.

Ag Biosystems Pvt Ltd. 12/2004 to 11/2005

Research Associate

Roles & Responsibilities:

Isolation and identification of industrially important microorganisms.

Biochemical analysis of antibiotics by HPLC techniques, Spectrophotometry etc.

Optimization of cultural conditions for the increased yields.

Scale up studies for different antibiotics.

Education:

M.SC Life Science, Osmania University. India

B.SC, Osmania University. India

Certifications:

Certification in Clinical Research And Clinical Data management

SAS Certified Based Programmer for SAS 9

SAS Certified Advanced Programmer for SAS 9

PL/Sql Programming Certified.

Technical Skills:

SAS Tools - SAS Base/SAS Graphs/SAS stat/Access/ Macros, SAS/ODS, SAS/REPORTS.

SAS Procs - Print, Means, SQL, Report, Freq, Sort, Summary, Format, Import, Export,

Transpose, Compare, Proc Append, Proc Datasets

Oracle Clinical, Medidata Rave Database /programming skills

Oracle, Visual Basics, PL/SQL, Tableau, Adobe Acrobat, InDesign CS6, PageMaker tools

Trained on clinical research development process, SOPs, good clinical practice the clinical data management process, clinical objectives and methodologies.

Good organizational and project/time management skills and excellent interpersonal skills.

Good knowledge of CDISC (SDTM, ADaM) data structures as well as a solid understanding of the development and used of standard programs

Working knowledge of FDA regulatory requirements, ICH guidelines, and good clinical practice

Knowledge of Medical terminology and 21 CFR part 11

Other Skills:

Onsite experience – Travelled twice to Basel on Business requirement

On Boarded new Vendor – involved in all steps from selecting the vendors, interviewing, budgeting to on boarding

Trained the CRO (ClinTec) on the Novartis processes, conducted class room trainings by travelling to their site.

Review/create Standard operation procedures, guidelines, business guidance etc.

Vendor management, resource planning.

Trained on Project Management Program.

Publications and Awards

2 Passion Quality Speed awards (Novartis)

Above and Beyond award (Novartis) for training and on boarding India vendor

Spot Awards (Novartis)

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