Name: DILEEP SAIRAM

Stream: M Pharmacy
Email: sairamdileep3@gmail.com
www.linkedin.com/in/dileep-sairam-720203172
Mobile: +91 7337896038

CAREER OBJECTIVE:
• To be associated with progressive organization that provides an opportunity for a challenging & rewarding career by applying my knowledge, skills and
potential in this profession.I would also like to make symbiontic contribution towards organisation by being innovative & prospective in the regular work
that I do that will enhance me up personally.

CORE COMPETENCIES:
• Clinical Research
• Medical Writing & Regulatory Affairs
• Clinical Research Operations & Clinical Trails Management.
• Project Management & Market Research

PROFESSIONAL EXPERIENCE:
Having Vast experience in Clinical Research, Clinical Operations such as On site Monitoring, Centralized monitoring & Clinica l Trails management such as Project
management, Clinical data management, Regulatory Affairs including Regulatory & medical writing.

WORK PROFILE:

Designation Organization Service

Medical Record Summarizer Medidocx services pvt. Ltd. May 2024 – Feb 2025
Sr. Clinical Project Associate. Covance India Pharmaceuticals Feb 2018 - July 2021

Clinical Research Associate. Lotus labs pvt. ltd Dec 2016 – July 2017

Clinical Research Associate/ Medical writer. Anacipher CRO Sep 2015 – March 2016

PROFESSIONAL SKILLS:
• Assign, analyze & complete Clinical trials related activities & tasks to verify & ensure the global level performance of clinical study in compliance to the project
budget & timelines.
• Study Start Up activities including Setting up & define the clinical studies in the centralized database, checking up continuously & re defining the study structure as
per the regulatory & updates to the study in regional & global level.
• Study maintenance roles such as Study Monitoring, Preparing of study updates & study reporting globally based on different task types.
• Laboratory operations including supervising & coordinating with the laboratories to effectively manage the clinical study related laboratory samples shipping &
management among sponsor & investigator sites, resulting, updating into database, data revision & accurate resulting, reporting in to different categories.
• Study Close out activities including monitoring study data lock & resolving pending activities, performing data sharing to client in the data sets for all the
laboratory results reported in study visits & schedule basis.
• Technical roles such as Study programming into the database, testing the efficacy & efficiency of the study tools for the increasing performance, performing access
controls based on study roles for personalized study performance.
• Oragnizational roles such as Supervising, Coordinating internal team functions, quality checks, audits & audit preparations, Conducting & organizing meetings,
Trainings etc.
• Organizational roles such as Business analytics, Defining programme & functions, Assigning & allocating work, preparing day to day reports to ensure the smooth
& effective progress of all volunteered & billable activities.
• Coordinating various aspects involved clinical phases studies at various levels. Prepare and maintain records and case files, including documentation such as
clients' personal and eligibility information, services provided, narratives of client contacts, and relevant correspondence.
• Handled Various Trial-specific Responsibilities at site level including setting Site qualification, setting up criteria for site selection.
• Compiling Study-specific Trial Master files, Case Report forms.
• Preparing CTDs such as ICDs, Technically and scientifically accurate study specific protocols.
• Participating in the implementation of trial.
• Administration of Investigational Products to human subjects. Efficient monitoring & accurate reporting of AEs to the Principal investigator.
• Coordinating with the investigators in making trial related decisions. Handling of amendments to Protocols etc.
• Providing and handling of accurate & reliable clinical trial data. Supervising the conduct of clinical trials.
 • Closing of clinical studies: Verifies the integrity of investigator files, ensures availability of clinical & non clinical materials; jointly reviews with investigators the
obligations inherent at the end of the study and writes closure visit reports.
• Writes initiation reports & follow up reports.
• Preparing CTDs such as ICDs, Technically and scientifically accurate study specific protocols. Participating in the implementation of trial.
• Administration of Investigational Products to human subjects.
• Performing the regulatory research, regulatory writing & finalizing the data according to the scientific sets of study master title.
• Compiling & submitting Regulatory documents, participating & coordinating regulatory activities to obtain the regulatory appr oval for the clinical study start up.
• Performing study conduct roles such as site monitoring, ACE reporting, reporting case report forms of trial related subjects.
• Compiling, preparing the trial master file, case report forms & completion of clinical records, clinical trial reporting to sponsor & approval.
• Medical Record Summarization:
• Review and summarize medical information such as Attending Physician Statements, lab reports, paramed exams, and/or other rel ated underwriting information
consistent per client specifications.
• Review case narratives & Queries on drug interaction and adverse effects on drugs.
• Detect, Interpret and update the treatment related information from the case of the patient which enable to convert physical health information into Electronic
Medical Record (EMR).
• Creating precise and informative medical summaries of patients.
• Interaction with managers regarding problem solving and understanding the process.
• Reviewing medical records and producing an accurate summary of the patient’s medical history.
• Verify and review all forms and documents about a case for errors, missing information, legibility; and request follow up information as required.
• Detect, interpret, and update the treatment-related information from the case of the patient which enable to convert physical health information into Electronic
Medical Record (EMR).
• Ensuring the creation of summaries that are precise and are backed by medical literature.
• Interaction with managers regarding problem-solving and understanding the process.
• Ensuring accurate and documentation of medical history, suspect drugs, and affiliated medications.
• Assess adverse event reports for seriousness, causality, and expectedness as per the appropriate label.
• Verify consistency between the source documents and the narrative summary.
• Adhere to AcroDocz’s information security guidelines.
• Medical Records Summarizer should be in the center of ethical behavior and never on the sidelines

CAREER ACHIEVEMENTS & EXCELLENCE:

• Awarded of process excellence level 2 by Covance India Pharmaceuticals Pvt, LTD- 2019
• Award of process excellence level 3 by Covance India Pharmaceuticals Pvt, LTD- 2019
• Award of process excellence level 1 by Covance India Pharmaceuticals Pvt, LTD- 2020

TECHNICAL SKILLS:
MS Office, Powerpoint, MS Excel.

ACADEMIA:

Name of course Institution Year of completion Percentage obtained

Master of pharmacy Max institute of pharmaceutical sciences, Khammam 2015 84 %

Bachelor of pharmacy Sree college of pharmacy, Khammam 2012 80 %

Intermediate Sree Chaitanya Junior college, Khammam 2007 69 %

ACADEMIC EXCELLENCE, PROJECTS & CERTIFICATIONS:

• Awarded as the best student- inter college level- years 2008 to 12, Sree college of pharmacy, Khammam dist., Telangana.
• Owned Research project- Formulation development and in-vitro evaluation of muco adhesive microspheres - Jan 2014 to Aug 2014, duration of 8 months. Did
under the guidance of Naga Kanyaka Devi, Ph.d pharmaceutics, Max institute of pharmaceutical sciences, Khammam dist.
• Certification of Post Graduate Diploma in computer applications
• Certificate in Diploma in Clinical Research., Clini India, Somajiguda- Hyderabad-500082

LINGUISTIC SKILLS:
English, Hindi, Telugu
ADDRESS:
9-95, Tallada, Khammam dist, Telangana
DECLARATION:
I here by signing below declare that the information provided me is true & I will be responsible for consideration of my profile based on this details.