Bandi Sharathchandra
Mancherial
Summary
I have completed my post-graduation degree in Doctor of Pharmacy, and currently working as an TMF project Management, had gained knowledge on regarding the study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans. And experience, I worked as Clinical Pharmacist in a hospital for a period of One year. My role is to verify complex diagnoses and facilitate treatment plans, provide patient care counselling sessions and identifying of untoward reaction, maintain of patient record, progress and concerns. Talented professional brings proven abilities in end-to-end project management. Expert in identifying and mitigating risks, reaching milestones, and managing deliverables. Highly organized leader with great attention to detail.
Overview
6
6
years of professional experience
Work History
Senior Project Manager ETMF
ELI LILLY SERVICES INDIA PVT.LTD.
Bangalore
08.2022 - Current
- Participate in collaborative initiatives with Global Patient Safety (GPS) concerning CIOMS form safety mailing.
- Demonstrated proficiency in Veeva Vault Systems, specializing in electronic trial master file management.
- Led cross-functional teams to deliver complex projects on time and within budget.
- Developed project plans, timelines, and budgets for multiple concurrent initiatives.
- Coordinated resources across multiple departments and teams to ensure successful completion of projects.
- Conducted cross checks and co-dependency checks to identify missing documents efficiently.
- Ensured effective organization, tracking, and retrieval of essential trial documents using Veeva Vault.
- Coordinated communications with clinical study sites, IRB/IEC, vendors, and study teams throughout study lifecycle.
- Generated Flash reports and metrics reports within vault clinical for performance tracking.
- Collaborated with project managers and site associates to set up External Service Providers for studies.
- Monitored day-to-day operations of External Service Providers to ensure compliance and efficiency.
- Applied ALCOA+ principles in reviewing quality documents to maintain high standards.
Clinical Documentation Specialist (Tmf DS II)
SYNEOS HEALTH- INVENTIV PHARMA INTERNATIONAL PVT.LTD
Hyderabad
03.2021 - 08.2022
- Process study documentation in accordance with Standard Operating Procedures (SOP’s), Work Instructions (WI’s), GCP, ICH guidelines and study specific TMF Plans.
- Support the set-up, maintenance, and closure of TMF repositories.
- Support documentation collection activities, including: Document scanning and indexing for trial using an electronic TMF, Document filing for trials using a paper TMF.
- Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified.
- Maintain compliance with departmental quality, performance, and utilization targets.
- Complete administrative tasks (e.g., status reports) as requested.
- Maintain compliance with company requirements (e.g., time tracking, training).
- Participates in preparation/reconciliation of TMF documentation related to audits, inspections and shipments.
- Participates in study specific training as required.
- For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate refiling upon return.
- Ensure that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room.
- Ensures the security and compliance of all documents related to active and archived project.
Clinical Pharmacist
Siva Subhramaniyam Hospital
Warangal
01.2020 - 02.2021
- Maintained accurate records of patient care, progress, and concerns.
- Educated patients on medication usage and potential side effects.
- Maintained accurate medication records and documentation systems.
- Provided counseling to patients regarding their medications including appropriate administration techniques as well as potential side effects or allergic reactions that may occur.
- Assessed medication appropriateness using evidence-based guidelines along with patient specific factors such as age, weight, concurrent diagnosis.
- Monitored of vital signs, such as Blood pressure and pulse.
- Cared for clients with Diabetic, Psychiatric, Hypertension and muscular dystrophy.
- Obtained information about client’s medical history, medication history, complaints and allergies.
- Assist with the physician and participate in the medical wards.
- Provide Pre -and Post-operative care therapy plan.
- Maintained a clean, healthy, and safe environment.
Education
Doctor Of Pharmacy -
Vaagdevi College of Pharmacy
Warangal01.2020
Intermediate -
Narayana Junior College
Hyderabad01.2011
SSC -
Krishnaveni Talent School
Mancherial01.2009
Skills
- Excel and Power BI
- Microsoft PowerPoint
- Cross-functional collaboration
- Clinical documentation and data management
- Team building
- Project management and multi-project oversight
- Good clinical practice knowledge
- Auditing compliance skills
- Training and mentoring capabilities
- Agile methodology application
- Vendor management strategies
- Analytical thinking and problem-solving
- Safety update reporting skills
- Veeva Vault management
- electronic trial master file
- electronic trial master file management
- Veeva Vault Systems
- Argus software proficiency
Accomplishments
- Completed an internship at Mahatma Gandhi Memorial Hospital, Warangal, for a period of one year, with the goal of improving therapeutic outcomes through safe and appropriate medication use.
- Collected 25 severe adverse drug reactions, which have been reported to the NCC PVPI Board.
- Organized and participated in a one-day national seminar held by Vaagdevi College of Pharmacy, Warangal, titled “Role & Responsibilities of Pharmacist in Clinical Practice” on April 12, 2017.
- Participated in and presented a case report on Stevens-Johnson Syndrome at a two-day national seminar on “Pharmacy Practice and Its Challenges” in March 2017.
- Participated in a national conference on “Pharmacy Practice and Education System in India: Prospects and Challenges,” held by the Pharmaceutical Association of Kerala, India, from April 11 to 9, 2016.
- Participated in the Indian Association of Colleges of Pharmacy event titled “Connecting Pharmaceutical Sciences and Knowledge Advancement,” held at St. Peter's College of Pharmacy, Warangal.
Languages
- English, Hindi, Telugu, Kannada
Timeline
Senior Project Manager ETMF
ELI LILLY SERVICES INDIA PVT.LTD.
08.2022 - Current
Clinical Documentation Specialist (Tmf DS II)
SYNEOS HEALTH- INVENTIV PHARMA INTERNATIONAL PVT.LTD
03.2021 - 08.2022
Clinical Pharmacist
Siva Subhramaniyam Hospital
01.2020 - 02.2021
Doctor Of Pharmacy -
Vaagdevi College of Pharmacy
Intermediate -
Narayana Junior College
SSC -
Krishnaveni Talent School