Project Management/Clinical Trials/Strategy/Operations

Depika Battu

*** ********** ****, ******, **, ***35 ***********@*****.*** 713-***-**** https://www.linkedin.com/in/depikabattu

Work Experience

Clinical Operations Associate, World Care Clinical LLC, DEC. 2015 – DEC. 2016

•Implementing Business Process improvements, which introduces consistency and quality, throughout the endpoint adjudication committee (EAC) workflow of multiple protocols allowing for scalability.

•Therapeutic area: Cardiology, Gastroenterology, Pulmonary, Rheumatology, Neurology, Oncology -Rheumatoid Arthritis, Cancer- GI, Lung, Lymphoma and Sarcoma, Opportunistic Infections.

•Follow Documentation and SSP's- Site Reporting Guidelines, Standard Queries, Site Requisition forms, eCRF's, PHI-Package Building, Adjudication Process

•Perform established processing techniques across multiple imaging modalities using proprietary and third party package software

•Assist in the training of Investigator Site personnel with image acquisition and/or transfer Generate queries and follow through to ensure resolution

•Report accurate information in a timely manner to incoming requests from CROs and/or Trial Sponsors

•Validate AE, SAE and Reportability Guidelines, Package Quality Control

•Experience working on projects that are in Phase 3 Clinical Trials Drug Development process

•Review and Billing invoices for different Projects for Multiple Vendors.

Education

Northeastern University, Boston, MA DEC 2016

Concentration in Clinical Trials GPA: 3.2/4.0 Related Courses: Project Management Best Practices, Project Risk Management, Managing Troubled Projects, Group Dynamics and

Interpersonal Conflicts, Global Project Management, Auditing and Validation of Clinical Trials, Project Scheduling and Cost Plan, Portfolio Management in Enterprise, Clinical Trial Design Optimization, Negotiation, Mediation and Facilitation

Jawaharlal Nehru Technological University, Hyderabad, India JUNE 2013

Bachelor in Pharmacy (B. Pharmacy) GPA: 3.6/4.0

Related Courses: Pharmaceutical Biotechnology, Pharmaceutical Technology, Pharmaceutical Organic Chemistry, Pharmaceutical

Biochemistry, Novel Drug Delivery Systems and Regulatory, Physical Pharmacy, Project Work, Pharmacognosy, Pharmacology, Clinical Pharmacy and Therapeutics, Medicinal Chemistry, Statistical Methods and Computer Applications

TECHNICAL SKILLS

Operating Systems: Windows, Mac OS X, and Unix/Linux

Tools: Microsoft Project, Microsoft Excel, Microsoft Word, FOXIT, World PRO, JIRA

PROFESSIONAL EXPERIENCE

ACADEMIC PROJECTS

Northeastern University, Boston, MA DEC 2016

•Project Management Best Practices: Designed a Project for aquatic swimming pool, Project Scope, Schedule and Cost, Risk Management Plan, Contingency Plan, Progress Report, Project Challenges like Insufficient Budget, Delay in Material Delivery.

Technologies/Tools Used: MS office suite, MS Project

Managing Troubled Projects: Research on various projects internationally, Solutions, cause and effects, determined best ways to solve the problems, benefits and risks of solution, recommendations to the Project

•Project Scheduling and Cost Plan: Developing business requirements, WBS, activities, network diagrams, critical path, resource

Optimization, schedule compression, cost planning, cost performance, setting project baseline, managing the schedule

•Risk Management: Identifying risk, qualitative analysis, quantitative analysis, developing risk response Strategies, risk control

•Clinical Trial Design Optimization: Ethical principles in clinical research, legal considerations, conflict of interest, randomization methods, impact of media in research.

•Capstone: Project Scope Management Plan, Build WBS, Stakeholder Management, Risk Register, Cost Management Plan, Risk Management Plan, Procurement Management Plan, HR Management Plan, Project Evaluation Report, Project Schedule, Set Baseline. Cost Estimation and Real time Project Time Management Plan, Contingency Reserve Funding Plan.

Jawaharlal Nehru Technological University, Hyderabad, India JUNE 2013

Pharmaceutical Analysis Project: Formulation and Evaluation of Fast Dissolving Tablets of Antihistamine

•Instrumentation and Methods: UV spectroscopy, mass spectroscopy, UV, infrared spectroscopy, Pre-formulation studies, determination of solubility, determination of melting point by open capillary method, determination of PH of a solution, pre-compression and post compression methods

CERTIFICATIONS

Registered Nurse: Pharmacy Council of India JUNE 2013

PROFESSIONAL ACHIEVEMENTS

Pharma Deep Industry: Seminars on Pharma industry birth and about manufacturing of drugs, research on top Pharma

Companies JUNE 2012

Contact this candidate