Baburao Goddali
Hyderabad
Summary
Experienced Clinical Project Manager with a background in overseeing clinical trials and managing cross-functional teams. Proficient in ensuring adherence to protocols, maintaining project timelines, conducting risk assessments, and preparing reports for regulatory bodies. Skilled at utilizing technical tools for data management and demonstrating effective communication skills. Past work demonstrates significant impact on improving efficiency of project delivery while maintaining compliance with industry regulations.
Overview
11
11
years of professional experience
Work History
Clinical Project Manager
VOIANT Clinical (Formerly World Care Clinical)
Hyderabad
04.2021 - Current
- Responsible for the delivery of VOIANT clinical products and services to sponsors within expected timelines and budget
- Lead, manage, and motivate the multidisciplinary team
- Resource planning and management
- Utilize project management tools to plan, track, prioritize, and communicate timelines and deliverables to the project team and sponsor
- Assess project quality and risk
- Proactively investigate and resolve issues
- Manage the study to contract, including proactive management of budget, pass-through costs, and contract amendments where necessary
- Actively manage the timelines considering the impact on resources and revenue forecasting
- Prepares the project timeline associated with the imaging process
- Conducts study start-up meetings (internal and external)
- Conducts ongoing study team meetings
- Performs scheduling of activities and deliverables in conjunction with the client and internal customers
- Conducts ongoing teleconferences with the client, managing the agenda and meeting minutes
- Provides timely notification of all appropriate parties with deviations from timelines and/or deliverables
- Conducts regular communication with team members, formal and informal, regarding study status or any other changes
- Utilizes delegation skills to obtain maximum productivity and team involvement
- Performs/facilitates project-specific team training
- Receives all necessary client signatures on the critical path
- Facilitates preparation of study analysis plan/Charter
- Manages Independent Review process
- Facilitates preparation of all study-specific manuals
- Maintains necessary 21 CFR Part 11 guidance documentation
- Maintains signed copies of all financial and study-specific documentation per the SOP
- Able to identify work done as it relates to study exhibit/contract (within or out of scope)
- May assist with therapeutic departmental strategies and goals
- Use autonomy and interpersonal skills to ensure that deliverables are met
- Ensure compliance with SOPs and other relevant FDA regulations.
Team Lead
PAREXEL International/Calyx
Hyderabad
10.2018 - 03.2021
- Prepare, monitor, and support the day-to-day tasks of the project team members based on study priorities set by OWM/PM/IOL
- May assist with client communication related to general or customized project status
- Provide directions to the project teams to work on data reconciliation and assist them in determining appropriate action
- Responsible for driving teams to achieve targets set by the Project Manager
- Responsible for communicating study progress to PM and IOL
- Responsible for facilitating project team communication across all locations
- Collaborates with management and team to troubleshoot technical, operational, and workflow-related issues
- Responsible for communicating resourcing, training, and other study-related requirements to the Line manager/Project Manager/Imaging Operations Leads
- Responsible for communicating performance issues or identified gaps in project teams to their respective Line Managers
- Identify the need for special skill sets and provide inputs to Management for the expansion of SME bench strength
- May provide feedback and evaluate the content of Project Plan, CIL, IAG, and SOM to ensure appropriate documentation of all operational activities
- Closely works with IOLs on project start-up activities
- Identifies issues and works with PM and IOL to determine the best course of corrective action for resolving them
- Ensures that confidentiality of study protocols and subjects is being maintained.
Senior Imaging Research Associate
PAREXEL International
Hyderabad
11.2016 - 10.2018
- Perform quality assurance checks on medical imaging data to ensure protocol-specific requirements are met
- Perform established image processing techniques like converting imaging formats, across multiple modalities (including but not limited to CT, MRI, and Ultrasound) using proprietary software as well as other third-party software
- Perform project-specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project-specific protocols
- Perform demonstrations of project applications (tracking, analysis, image viewers, etc.) and image processing techniques to clients, auditors, and internal personnel
- Perform site training visits and/or investigator meeting presentations for assigned projects
- Act as liaison with investigator site personnel and independent reviewers to resolve issues that arise over the course of the clinical trial
- Ability to prioritize and manage time-sensitive tasks for multiple projects
- Assist with the training and mentoring of Imaging Research Associates, Imaging Assistants, and new hires
- Assist with expanding subject matter expertise for specific modalities and therapeutic areas
- Work closely with the product development teams to provide enhancement requirements and assist with resolving technical issues
- Work with the Imaging Support Group to explore new tools and software to increase efficiency
- Effectively contribute to global harmonization processes
- Perform other duties as required by the position.
Imaging Research Associate II
PAREXEL International
Hyderabad
11.2015 - 10.2016
- Took a lead role in mentoring and assisting in the training of internal personnel
- Perform quality checks of specialized modality (Echo)
- Perform established image processing techniques like converting imaging formats, across multiple modalities (including but not limited to CT, MRI, and Ultrasound) using proprietary software as well as other third-party software
- Monitoring within assigned projects of Good Clinical Practices (GCP), additional regulatory requirements (21CFR Part 11), applicable departmental and companywide SOPs, and project-specific protocol compliance.
Imaging Research Associate I
PAREXEL International
Hyderabad
12.2013 - 10.2015
- Ensure the site personnel have a good understanding of the requirements of the study
- Working with investigator site on-site surveys and site qualification
- Perform image processing (including the downloading of imaging data from media, Digitizing data entry
- Perform established image processing techniques like converting imaging formats, across multiple modalities (including but not limited to CT, MRI, and Ultrasound) using proprietary software as well as other third-party software
- Validate and maintain imaging database including image and tracking and review results for assigned Projects
- Querying and following up with sites to resolve imaging issues
- Maintaining spreadsheets pertaining to the project work assignment.
Education
Master of Science - Microbiology
Osmania University
01.2013
Bachelor of Science - Microbiology
Sri Sai degree college
01.2011
Intermediate -
Intermediate Board of Hyderabad
01.2005
SSC -
Holy Spirit High School, Hyderabad
01.2003
Skills
- Optimistic
- Meticulous
- Target oriented
- Good analytical skills
- Quick learner
- Exemplary analytical skills
- Problem-solving skills
- Interpersonal skills
- MS Office packages
- Ms word
- Excel
- Powerpoint
- VBA
- Macros
- Oracle Billing and Invoicing Finance Tools
- Image transfer systems AG Mednet and Ambra Health
- Medidata
- Parexel/ Calyx systems
- PMED
- Perceptive MyTrials/my queries
- Experience working with Medical Imaging Core Applications and software
- Clinical Research
- Project Planning
- Stakeholder Communication
- Clinical Documentation
- Training and mentoring
- Compliance with regulatory guidelines
- HIPAA Compliance
Disclaimer
I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned information.
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
French
Beginner
A1
Timeline
Clinical Project Manager
VOIANT Clinical (Formerly World Care Clinical)
04.2021 - Current
Team Lead
PAREXEL International/Calyx
10.2018 - 03.2021
Senior Imaging Research Associate
PAREXEL International
11.2016 - 10.2018
Imaging Research Associate II
PAREXEL International
11.2015 - 10.2016
Imaging Research Associate I
PAREXEL International
12.2013 - 10.2015
Master of Science - Microbiology
Osmania University
Bachelor of Science - Microbiology
Sri Sai degree college
Intermediate -
Intermediate Board of Hyderabad
SSC -
Holy Spirit High School, Hyderabad