Clinical Research Associate
Resume:
Sandhya SD
[**]
[***********@*****.***;***********@*****.***]
[https://linkedin.com/in/dr-sandhya-sd-2283b0120]
Versatile, goal-oriented research professional with 4+ years of Clinical Research experience. Covered all aspects of administration, management, mentoring, execution, training and organizing required tasks in my level. Gained strong foothold in the areas of Centralized Monitoring. Successful at managing multiple priorities with positive attitude and willingness to take on added responsibilities to meet personal and company goals. Seeking to challenging position where I can learn more from organization contribute in best possible way to company and society. Skills
• Time management, Risk management
• Strong customer focus and keen eye for details
• Work independently
• Microsoft office (Word, Excel and PowerPoint)
• Self-motivated
• Presentation and communication
• Critical thinking, strategic thinking and decision making
• Knowledge of project management
• ICH-GCP understanding
• Good communication skills (Verbal and written)
• Innovative, Multi-tasking, Quicker learner
Work Experience
[01-OCT-2020 – TILL DATE]
[Centralized Monitor-RISK BASED MONITORING] / [IQVIA, Bangalore]
[NOC Code: 4165]
Overview of access request management, action item management, Key Risk Indicators analysis, KRI alerts management, I site Pack preparation, Trend analysis and historic site performance according to Central Monitoring Plan, Early identification of site-level risk/issue(s) occurring during study conduct, monitor site performance and make recommendations for timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit) and checking if no effect is observed. Data cleaning for responsible sites (Open queries, missing pages, eTMF overdue unfulfilled placeholders, SDV count), Worked during IDBL for a project, used various strategies to reduce overdue count and also strategies worked to keep data clean. Better understanding of CM Platform, CTMS and many other systems. Worked on Oncology, Narcolepsy, hematology, Psoriasis studies. Knowledge of site initiation to site closure activities. Work in close with RSU, CTA and CRA team to keep eTMF clean and data ready. Supervise Centralized Monitoring Assistant in terms of Access management, CTAs in terms of pending documents. Knowledge of site initiation to site closure activities, drug development process. Received Silver award.
[28-SEPT-2018 – 30-SEPT-2020]
[Centralized Monitoring Assistant] / [IQVIA, Bangalore] [NOC Code: 4165] Worked on Access management for various internal and external vendors systems, supporting team to monitor the sites remotely for site readiness and making sure the site is ready, mentoring new team members at same level regarding various tasks of project, managing site initiation tasks, updating internal systems, managing and uploading documents in eTMF, maintaining collaboration with team and site, reports and maintaining various trackers and maintaining Investigator Site File Binders. Worked on Oncology studies and mainly in site startup phase. Received Various Awards throughout this period like Bravo, and ecards from project leads.
[21-May-2018 – 21-Aug-2018]
Clinical Research Associate] / [Clinical Research Oncology Network, Hyderabad] [NOC Code: 4165] Prescreening of patients into the study based on inclusion and exclusion criteria, handling of protocols, preparations of source documents in EDC (Medidata). Worked on Oncology studies (non-small cell lung cancer, breast cancer)
[05-MAY-2017 – 05-MAY-2018]
[Clinical Pharmacist] / [Gandhi Hospital, Hyderabad] [NOC Code: 4165] Departments: Pediatrics, Orthopedics, General Surgery, General Medicine, Gynecology and Psychiatric 2
Responsibilities: Trained to perform drug-drug interaction findings, counselling of patients, adverse reactions, clearing the drug related queries of doctors, involved in different case collections and analysis of disease condition and treatment plans for the cases.
Education
[2022]
[MBA IN Healthcare Management] / [Welingkar Institute of Management, University of Mumbai] Scored 71%, gained management knowledge, hospital settings, budget management, human resource management, etc. MBA assignments and projects has encouraged to think in management prospective. 2018]
[Doctor of Pharmacy] / [CMR College of Pharmacy, Hyderabad] Scored 71.4%, gained immense knowledge of medicines, diseases, pathophysiology, etc. This included ward round participation, medication history interview, treatment chart review, poison and drug information (PDIC), patient counselling, drug interaction, ADR monitoring, case presentations. Activities
MEMBERSHIP: Volunteered for National Forum of Pharmacy Students. This opportunity gave chance to get involved in new things, meet new people, improve communication skills, gain confidence and mainly helped me to make a difference.
PROJECTS and PUBLICATIONS:
1) Empirical therapy of antibiotics in surgical site infections - 6 Months 2) Definitive therapy of antibiotics in surgical site infections - 6 Months 3) MBA main Project - A Study on trends and dynamics of the healthcare industry in India - 6 Months 4) Review Article Publication: Surgical Site Infection 5) Case Study Publication: Port Site Infection, Amlodipine induced pedal edema CERTIFICATIONS:
1) Project management certification 2022 from Skill Up trainings 2) ICH-GCP Trainings, Certification from NIDA & IQVIA, latest 2022 3) CRA trainings, Certification from Learning Edge Company’s internal, 2022 4) Received verification from international Academic Qualification froms Canada. LANGUAGES: English, Hindi, Telugu, French (Beginner to Read, Write and Speak) DECLARATION: I hereby declare that the information furnished above is true to the best of my knowledge. Date: 14-July-2022
Place: Bangalore
Sandhya SD
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