Summary
Overview
Work history
Education
Skills
Certification
Additional Information
Languages
Timeline
Generic

SAMATA TUMMETI

Dublin,Ireland

Summary

· Highly skilled in managing project deliverables and milestones, including personnel and resource allocation, tracking project scope, budgets and timelines

· Hands on experience in Salesforce.


  • Provided support to the project Leaders on the team to successfully deliver change within the Risk Function.
  • Collate and develop monthly reporting packs by engaging with key stakeholders to document project progress, review and challenge inputs and ensure status is accurately reflected.
  • Using key project metrics to provide insightful commentary and MI for senior Risk management & stakeholders.
  • Support the management of change requests from the business, helping to articulate these in simple language and track/monitor status updates, issues and budgets.
  • Track RMP delivery for Risk, ensuring stakeholders adhere to reporting and submission timelines.
  • Ensuring issues are escalated to the Head of the team in a timely manner.
  • Day to day support to Lead PM and head of Risk Projects on other ad hoc tasks.

· Actively involved as Project Data Coordinator, Subject Matter Expert for PDC group in the organization, participated in different aspects of project life-cycle and delivered high-value project management activities across projects

· Proficiently serving as a member of project teams to assure that functional deliverables are supplied on time, on budget and according to quality standards

· Efficiently coordinating project team meetings (scheduling, agenda preparation, material preparation, minute’s distribution), decent understanding and knowledge of adverse events, SAE form, SAE time line submissions, ARGUS database, drug development procedures, preclinical and clinical Trials

· Assisting with developing proposals for clients and assist with management of budgets and contracts, upholding current knowledge of PK and PK/PD science, GCP and ICH guidelines, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices and established sound knowledge on various clinical systems, processes and project management activities

· Excellent verbal and written communication skills, with proven experience developing and presenting project status reports and engaging with leaders and peers to address any challenges and facilitate teamwork to resolve any issues

· Conducting an on-going review of processes to ensure consistency across projects, including identification and implementation of solutions

Overview

4
4
years of professional experience
2
2
years of post-secondary education
1
1
Certification

Work history

Sr.IPT Project Coordinator

IQVIA RDS Private Limited

· Provide customers, staff or stakeholders with projects, systems or technical support in line with project plans or initiatives in Sales force system

· Provide internal/external customer facing support in study hub System. Provide support to the project manager(s) on the team to successfully deliver change within the Risk Function.

· Collate and develop monthly reporting packs by engaging with key stakeholders to document project progress, review and challenge inputs and ensure status is accurately reflected.

· Using key project metrics to provide insightful commentary and MI for senior Risk management & stakeholders.

· Support the management of change requests from the business, helping to articulate these in simple language and track/monitor status updates, issues and budgets.

· Track RMP delivery for Risk, ensuring stakeholders adhere to reporting and submission timelines.

· Ensuring issues are escalated to the Head of the team in a timely manner.

· Day to day support to Lead PM and head of Risk Projects on other ad hoc tasks.

· Participate on teams (internal or external to IPT) as assigned.

· Identify quality issues and support corrective action plans and preventive measures. Escalate risks/issues as appropriate.

· UAT validation.

· Create, maintain and review system or process documentation and guidelines with guidance.

· Maintain quality standards, assist with trend analysis and track user requests for enhancements. Track and provide data for project updates. Escalates as appropriate.

· Maintain compliance with eSOPs, training and keep current on knowledge and relevant initiatives.

· Participate in change initiatives; active change advocate.

Project Specialist

03.2017 - 02.2020

· Dynamically involved in projects to support the Project Leader, internal systems and system set-ups and executing day-to-day data analysis and reporting activities

· Setting up of tools according to GPL SOPs (PMP, SOP list, TIME codes list, Team list, Project specific training management in LMS) and collaborating with the system setup analyst to ensure that systems (IH, PVw, PMED, SO, TARGET) and system interfaces are operational

· Systematically planning, providing, reviewing and analyzing reports to highlight critical issues and maintaining the project schedule and CTMS updated, also constantly interacting with study, research teams and sponsors

· Monitoring compliance heads-up of systems involved in projects (IH, PVw, PMED & forecasting tools) and ensuring system data or compliance disputes are surveyed up and resolved regularly

· Accountable for drafting steady coherent strategy, planning, coordinating, accumulating inputs from different functions by collectively integrating all fragments (scope, deviations, threats, quality standards, communication, schedule, procurement, and resources)

· Applying effective project management methodologies, quality & control techniques, optimization, inspection, internal and external audits and risk-based testing to attain the defect free output of the projects to ensure successful completion of the project

· Conducting internal and client meetings, preparing and monitoring review reports, by maintaining minutes of the meeting for attendees, tasks & follow ups, recommendations to improvise and tracking progress of the project utilizing appropriate tools to support the team lead

· Reviewing and processing pass through cost invoicing, analyzing labor working hours, tracking any inconsistencies and wrong bookings for PL review and final sanctions

· Verifying and safeguarding all systems are up to date with final information and all issues are addressed and closed during project closures

· Collaborating with PL on ensuring that documents are archived and final work handed-over to the sponsor.

· Liaising with vendors when work is outsourced, design office or anything else as required

Project Data Coordinator

05.2016 - 03.2017

· Keenly participated in taking specific responsibilities in single and centralized teams, by managing internal reporting, documentations to complete activities for project teams worldwide and taking ownership of client deliverables

· Systematically managed all administrative activities with regards to timesheets, metrics, system access management for a project, program or partnership in a timely manner, also owned delegate responsibilities within partnership/projects/programs to provide/revoke/manage accesses for PAREXEL team members through Internal/External systems

· Maintained a positive, results orientated work environment, building partnerships and modeling teamwork, communicating and keeping transparency to achieve desired results

· Provided extended support in assigned projects by mentoring, motivating, conducted trainings for team members and juniors PDCs

· Updated, and maintained reports from Internal/External systems and databases with attention to detail, also prepared, analyzed metrics and status reports gathered from various sources to deliver the information to all project teams

· Participated in Internal Progress/Metric Review meetings, recommendations and formal staff review processes regarding performance & salary reviews as per corporate standards and timelines

Education

MSc - Business Analytics

Dublin Business school
2023

Master of Science - Pharmacy & Pharmaceutical Quality Assurance

Kakatiya University
Warangal, India
09.2013 - 06.2015

Advanced - Clinical Research, Clinical Data Management

Clini India
2015

Bachelor of Science - Pharmacy

Kakatiya University
2013

Skills

  • SQL
  • Python
  • Power BI
  • Quality Control Procedures
  • Interpretation of Clinical Data
  • Reports & Documentation
  • Full Life Cycle Management
  • People Management
  • Research Protocol
  • Product Evaluation
  • Time Management
  • Stakeholder Management
  • Health & Safety Management
  • Compliance Adherence
  • Instrument Maintenance
  • Research& Project Proposals
  • Salesforce administration

Certification

Power BI Quality Control Procedures Interpretation of Clinical Data Reports & Documentation Full Life Cycle Management Statistical & Information Analysis Machine Learning Salesforce Stakeholder Management Health & Safety Management Compliance Adherence Instrument Maintenance Research Project Proposals SQL People Management Research Protocol Product Evaluation Time Management Customer Relationship

Additional Information

  • / Holding 1G visa
  • Highly skilled in managing project deliverables and milestones, including personnel and resource allocation, tracking project scope, budgets and timelines Hands on experience in Salesforce. Provided support to the project Leaders on the team to successfully deliver change within the Risk Function. Collate and develop monthly reporting packs by engaging with key stakeholders to document project progress, review and challenge inputs and ensure status is accurately reflected. Using key project metrics to provide insightful commentary and MI for senior Risk management & stakeholders. Support the management of change requests from the business, helping to articulate these in simple language and track/monitor status updates, issues and budgets. Track RMP delivery for Risk, ensuring stakeholders adhere to reporting and submission timelines. Ensuring issues are escalated to the Head of the team in a timely manner. Day to day support to Lead PM and head of Risk Projects on other ad hoc tasks. Actively involved as Project Data Coordinator, Subject Matter Expert for PDC group in the organization, participated in different aspects of project life-cycle and delivered high-value project management activities across projects Proficiently serving as a member of project teams to assure that functional deliverables are supplied on time, on budget and according to quality standards Efficiently coordinating project team meetings (scheduling, agenda preparation, material preparation, minute's distribution), decent understanding and knowledge of adverse events, SAE form, SAE time line submissions, ARGUS database, drug development procedures, preclinical and clinical Trials Assisting with developing proposals for clients and assist with management of budgets and contracts, upholding current knowledge of PK and PK/PD science, GCP and ICH guidelines, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices and established sound knowledge on various clinical systems, processes and project management activities Excellent verbal and written communication skills, with proven experience developing and presenting project status reports and engaging with leaders and peers to address any challenges and facilitate teamwork to resolve any issues Conducting an on-going review of processes to ensure consistency across projects, including identification and implementation of solutions

Languages

English
Advanced

Timeline

Project Specialist

03.2017 - 02.2020

Project Data Coordinator

05.2016 - 03.2017

Master of Science - Pharmacy & Pharmaceutical Quality Assurance

Kakatiya University
09.2013 - 06.2015

Sr.IPT Project Coordinator

IQVIA RDS Private Limited

MSc - Business Analytics

Dublin Business school

Advanced - Clinical Research, Clinical Data Management

Clini India

Bachelor of Science - Pharmacy

Kakatiya University
SAMATA TUMMETI