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Clinical Research Project

Location:
Eagleville, PA
Salary:
$55/hr
Posted:
December 28, 2020

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Resume:

Lakshmi Raparthi

Email ID: adi0dd@r.postjobfree.com

Phone: 732-***-****

SUMMARY

A dedicated and highly motivated professional with project management knowledge and experience in handling diverse projects and possess great ability in managing and work collaboratively with multiple project teams. Proficient in strategic planning, prioritizing and completing tasks in a timely manner.

WORK EXPERIENCE

GLAXOSMITHKLINE Collegeville, PA November 2018 - Present.

Clinical Project Associate

•Assisting in planning, managing, organizing and executing on going tasks for clinical studies and developing strategies for specific processes and ensure team receive the support needed to meet customer expectations on time and within budget.

•Work collaboratively and serve as point of contact for study related communications with the study teams, CROs, Vendors and participate in identifying critical issues concerning clinical trials with departmental heads. Ensure information in clinical data and project management systems (CTMS) is up to date.

•Facilitate processes for preparation of clinical regulatory documents, ensuring timely IRB approvals for clinical trials and Track study progress ensuring timely data collection, monitoring and, in collaboration with data management, internal listings reviews.

•Provide operational and technical support directly or/ by supporting study teams at the Global/Regional, Country and Investigator levels. Request, receive, QC and process all required regulatory, financial and legal documents, submit and obtain regulatory approval.

•Work cross-functionally to ensure clinical Study timelines, drug shipments and goals are met. Oversee study budget and responsible for the SVT (Subject Visit Template) creation process for Inhouse studies.

•Proactively participate in study meetings and demonstrate strong communication and negotiation skills that strategically influence internal and external partners to ensure that they have current and accurate information regarding project activities.

•Proactively interpret, draw valid conclusions, and summarize information from systems to support clinical projects, including the development of complex/innovative information management solutions and systems.

GLAXOSMITHKLINE (GSK) Collegeville, PA July 2017 - November 2018

Clinical Operations Associate

•Assisted in improving clinical research process by providing support on the Electronic Trial Master File (eTMF) business process and identifying opportunities for rearrangements.

•Participated in operational improvement and assisted TMF analyst in periodic reviews, document filing, and Analyzing eTMF queries being issued to identify trends and training needs.

•Supported Clinical Research Associates in eTMF query resolution and artifact uploading.

•Supported Local Study Managers with development of the study specific eTMF plan and folder/subfolder creation and maintenance of local and central ICE/IRB submissions and approvals.

•Engaged with other areas as well as third party vendors to modify current processes to decrease the number of queries issues and maintenance of electronic document filing systems.

AXA LIFE SCIENCE PVT LTD Hyderabad, INDIA April 2016 - August 2016

Team coordinator

•Provided the team with a vision of the Products. Coordinated with internal and external customers and familiarized the team with the customer needs, specifications, design targets, and drug standards.

•Assured that the team addresses all relevant issues within the specifications and various standards.

•Implemented team-building skills and work with different management levels on regulatory issues and obtain necessary resources to support the team’s requirements.

•Coordinates meetings with the product committee to discuss about impediments, needed resources or issues/delays in completing the task and track schedules.

•Provided quality customer service, including interacting with customers, answering customer inquiries, follow up with clients and effectively handling customer complaints.

•Supported in recordkeeping and documentation preparation. Assisted in all areas of responsibility, including interpreting and enforcing paper and electronic documentation.

GOLDFISH PHARMA PVT. Ltd. Hyderabad, INDIA May 2015 –Oct 2015

Quality Assurance Associate

•Gained experience in Quality and regulatory compliance and the methods of Production, Quality control, Quality assurance, formulation, and development of API by the following cGMP.

•Evaluated products using SOPs of various apparatus and review product labeling according to protocol. Prepared product related presentations and documentation.

•Coordinated with other team members for developing and implementation of the SOP. Shadowed product sample analytical testing.

•Reviewed quality system documents to determine compliance with regulatory regulations and cGMP and GLP standards and assisted in maintaining batch records.

EDUCATION

Master of Science (MS) in Project Management Concentration: Clinical Trial management.

Northeastern University, Boston, MA.

Research and Projects:

•Research kit for clinical trials for Alzheimer’s Disease (ALZI TRACK)

− Designed an application template for Apple iPhone that could be used by patients to participate in a clinical trial which is under recruiting status in clinicaltrials.gov.

− Designed an app template for apple I phone application which takes through the whole consent process and records clinical data

•Informed Consent Form

− Documented informed consent form for Alzheimer’s research study which gives details about protocol as per IRB requirements.

•Regulatory strategy for Anti-cancer drug

− Developed, designed and documented the regulatory strategy IND Submission and NDA Submission for the virtual product

− Classified the product based on FDA guidance for RFD submissions. − Documented labeling requirements.

•Regulatory strategy pathway for orphan drugs

− Developed pathway for obtaining orphan drug designation for sickle cell anemia drug.

•Clinic track mobile application project

− Developed Business case, Project Charter, Scope statement and Risk register for Clinic track application.

− Identified methods for evaluating a project’s viability in initial phases by using risk analysis, cost-benefit analysis methods.

− Prepared RACI Chart, traceability matrix, scope change request form.

− Designed Work breakdown structure, resource allocation, scheduling and task assignments using MS Project.

− Developed Cost Management Plan which defines how the cost of a project will be managed throughout Project’s lifecycle.

Bachelor of Pharmacy (B. Pharmacy)

Sarojini Naidu vanita pharmacy maha Vidyalaya, Osmania University, Hyderabad, India.

CERTIFICATE COURSES

•Harvard Manage Mentor – Harvard Business school

•Good Clinical Practices – NIH (National Institute of Health)

•Protecting Human Research Participants – NIH (National Institute of Health)

•Clinical Data Management Course (CDM). – ACRS Institute.

TECHNICAL SKILLS (PROFICIENT)

MS. Office (365): Word, Excel, PowerPoint, Outlook, Project, Access, SharePoint, Teams.

Clinical systems: Oracle clinical (e-TRACK), EndNote, Minitab, Bio Documentum, CTMS, e-TMF CARS, Veeva Vault, InForm, RAMOS NG.

Experience in using: MedDRA, WHO Drug data dictionaries, and clinical trials.gov.

Clinical understandings: FDA Regulations, ICH/GCP guidelines.



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