Project Management Team Members

Anju Kumari

Hyderabad ****** Mob. No. 974******* Email ID. ********@*****.***

Summary:

Productive employee with proven track record of successful project management and producing quality outcomes through leadership and team motivation. Works with pharmaceutical clients to determine requirements and provide excellent service.

Area of Experience:

Coordination of eTMF/Project file set up,

Project Plan,

UAT testing,

Data Validation plan,

Communication Plan,

eCRFs/ eOCRFs,

Data monitoring and reconciliation,

DM Platform/ EDC,

Export report and data transfer specifications

Collaboration with cross-functional study team

ICH-GCP

Regulations/guidelines

Professional Experience:

Scientist, Medical & Scientific Operations 17/Mar/2022 – 31May2024 Calyx International Hyderabad, India

Served as scientific lead for the assigned projects for scientific input and support as required to evaluate safety or efficacy of investigational drugs or medical devices.

Directly involved in project related aspects of application development, medical documentation, and reviewer quality control from a medical / scientific perspective in consultation with the relevant internal support and stakeholders.

Managed 17+ Phase I – III studies including RECIST 1.1, mRECIST, iRECIST, Lugano (both PET & CT based), MSK

Supports clinical teams from study start-up through closeout, including imaging core lab selection, KOL/core lab interactions; protocol and imaging document development (i.e., site manuals, charters, data transfer plans) and operational guidance to teams and sites

Lead initiative within the Calyx imaging group for imaging vendor training to internal Calyx team members to bridge the gap between sites, internal team members, imaging vendors to create a more harmonious relationship. Presentations developed and given to all previously mentioned groups throughout the past year and have received positive feedback on benefits to multiple trials within the portfolio

Provides operational guidance to team and sites along with clinical team training and education

Ensures delivery of image data per pre-defined timelines and specifications while performing risk management and monitoring imaging issue resolution

Supports due diligence efforts required to qualify imaging core labs and sites for participation in both novel and strategic relationships requiring imaging capabilities

Collaborated with management and team to troubleshoot technical, operational and workflow related issues.

Provided medical and scientific leadership for clinical trials where imaging and/or clinical data is used.

Identified key data insights through patient-level review and trend analysis.

Supported as a lead for interim analysis, database lock and site central discordance activities.

Ensured consistent application of protocol level deviation and study assessment.

Led studies in maintenance or in closeout phase or ongoing studies post primary database lock, as assigned.

Maintained accuracy of trial information in all trial databases and tracking systems. Attended relevant meetings to support ongoing execution of clinical trial and program level activities.

Maintained a good collaboration with cross-functional study team members for program specific standards/activities

(e.g., eCRFs/oCRFs, UAT testing, database specifications, Data Validation plan, outsourcing specifications including medical imaging, data monitoring, Export report and data transfer specifications) are applied to the clinical trial, where applicable.

Assisted in the creation of study specific documents and plans (e.g. Communication Plan, Project Plan, Monitoring Plan, monthly Status Report etc.), study logs (e.g. Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g. training tracker, FAQ, etc).

Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, Company Appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client. Team Lead/Process Specialist 06/Apr/2019 – 17/Mar/2022 Parexel / Calyx International, Hyderabad, India

Prepared, monitored, and supported day to day task of the project team members based on study priorities set by PM/IOL.

Provides project management and operational support for the imaging component of clinical trials across all therapeutic areas

Managed 17+ Phase I – III studies including RECIST 1.1, mRECIST, iRECIST, Lugano (both PET & CT based), MSK

Supports clinical teams from study start-up through closeout, including imaging core lab selection, KOL/core lab interactions; protocol and imaging document development (i.e., site manuals, charters, data transfer plans) and operational guidance to teams and sites

Lead initiative within the Calyx imaging group for imaging vendor training to internal Calyx team members to bridge the gap between sites, internal team members, imaging vendors to create a more harmonious relationship. Presentations developed and given to all previously mentioned groups throughout the past year and have received positive feedback on benefits to multiple trials within the portfolio

Provides operational guidance to team and sites along with clinical team training and education

Ensures delivery of image data per pre-defined timelines and specifications while performing risk management and monitoring imaging issue resolution

Supports due diligence efforts required to qualify imaging core labs and sites for participation in both novel and strategic relationships requiring imaging capabilities

Collaborated with management and team to troubleshoot technical, operational and workflow related issues.

Supported for communication resourcing, training, and other study related requirements to the line manager/Project Manager/Imaging Operation Leads.

Provided feedback and evaluated content of project plan, CIL, IAG and SOM to ensure appropriate documentation of all operational activities.

Identifies issues and work with PM and IOL to determine best course of corrective action for resolving them.

Ensures that confidentiality of study protocols and subjects is being maintained.

Assisted in performing quality checks on study images if required.

Assisted in performing Site and Project team trainings if required.

Executed Technical and clinical functions as required by the study protocol in accordance with GCP and SOPs.

Performed other duties as required by the position. Project Assistant 09/Feb/2015 – 08/Jun2018 PPD Development LLC, Bangalore, India

Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and Client Company Appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client.

Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner.

Supported for Post and distribute CTMS project specific guidance document to project team (if applicable).

Oversee the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments.

Coordination of eTMF/Project file set up.

Upon direction of CTM/PM, finalize the table of content for all study files (Central, Internal, Country, Investigator), develop and distribute filing guidelines to clinical team.

Performed file reviews and data reconciliation and log outstanding issues in project related tracking tools.

Reviewed Submission of documents to Central and Internal files and update in CTMS.

Developed and maintained assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines.

Assisted in the creation of study specific documents and plans (e.g. Communication Plan, Project Plan, Monitoring Plan, monthly Status Report etc.), study logs (e.g. Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g. training tracker, FAQ, etc).

Clinical Trial Assistant 06Jan/2014 – 02/Feb/2015 (1 Year) Quintiles, Bangalore, India

Processed Reimbursement payment to the investigator and sites for study visit forms.

Generated invoices for study visit forms by using EDC (Electronic data capture) System.

Generated quantitative and qualitative periodic update for reimbursement payment by using (Electronic data capture) EDC system.

Coordinated respective study Trial master file document with PEFD (Project email filling database) and PSO (Project support office).

Migration end-to-end of study level data into the Clinical Trial Management System (CTMS).

Facilitated integration of study level data virtually to ensure smooth functioning of clinical systems.

Coordinated with all respective stake holders to ensure timely deliverable of finished serviceable study on clinical system.

Provided quantitative and qualitative periodic updates on progress of integration.

Supported and shared knowledge with study team on specific to obtain valuable information.

Assisted for On-time query resolution.

Therapeutic Area Expertise:

Non-Small Cell Lung Cancer Phase 3

BREAST CANCER Phase 1and 2

Syndromic Obesity Phase 3

Obesity, Bone Age Phase 3

Bone Age Score, Growth Hormone Deficiency (GHD) Phase 3 Education:

Orissa University of Agriculture and Technology- Bhubaneshwar MSc. Bioinformatics Year 2011

Andhra University – Vishakhapatnam BSc. Biotechnology Year 2009

Diploma in Clinical Research, Clinical data Management and Base SAS Year 2013 Technical Skills:

Medical Quality Check of radiology and oncology assessments

Independent reviewer trainings

Medical image processing

Oncology Assessment Criteria (RECIST 1.1, Lugano 2014, MSK)

ICH-GCP

Clinical research

Clinical operations

Drug development process

Clinical study/trial design

Statistics/ Data reconciliation

Regulatory documents

MS Office, Microsoft Word/Excel/PowerPoint

Soft Skills:

Team management

Central reader training

Clinical project management

Client Negotiation

Mentoring Team

Language: Hindi, English

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