Devashish kumar

Clinical Research and PMI-CAPM certified Project Management professional with extensive experience in clinical Research and ensuring successful project completion and delivery. Skilled in working with cross-functional team, proficient in implementing clinical research methodologies, technologies and platforms. Able to work independently and possess a proactive and innovative problem-solving mindset. Looking opportunity to utilize my skills to help the senior team align project objectives with the strategy and ethics of the organization.

In my previous role, I was responsible for site management regulated and unregulated studies to ensure successful conduct of clinical programs and cross-functional strategies.

Please consider my qualification and experience:

• Experienced in clinical research and PMI-CAPM certified project management professional.

• Experienced in BA-BE studies, Phase-three trials and eTMF and SMF in virtual environment.

• Knowledge in guidelines ICH-GCP (E6), PMIBOOK and Project Modules

• Well aware of Clinical software

O Redcap, Citrix, Ovis

• Project management software

O Trello, Asana, Fog bogz, Tableau, 

• Microsoft 

O MS- Project, Power BI (Intermediate), Visio, Publisher, Access, Team and Office

• Methodologies

O Waterfall, Agile, Scrum, Six Sigma, Lean 

• Excellent oral and written communication skills, interpersonal skills, customer relationship, multitasking and organizational skills.

I would be thankful if I get a chance to prove my skills and interest in your organization. As an enthusiastic lifelong learner, I would appreciate the opportunity of an interview.

Thank you for taking your time to review my application.

Sincerely,

Devashish Kumar

Quest Life Sciences (P) Ltd

Clinical Research Associate (CRA) (2013 – 2015)

• Monitoring BE and Phase III studies
• Site Feasibility / Qualification Visit
• Routine Monitoring to Site
• Site Initiation / Interim Visits
• Oversee and Manage Independent Ethics Committee (IEC) Submissions
• Acting as a main line of communication between the Sponsor and the PI
• Verifying the PI follows the approved protocol & all approved amendment(s)
• Verifying that the ICF was obtained before each subject’s participation
• Reporting the subject recruitment rate
• Verifying that the source documents and other trial related documents accurate, complete, kept up-to-date and maintained.
• Verifying that the Adverse Events, Concomitant Medications, and inter- current illnesses are reported in accordance with the protocol on the CRFs.
• Verifying that the Investigator provides all the required reports, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated and identify the trial.

ICON Clinical Research Pvt. Ltd 

Document Management Assistant (2015– 2016)

• Work on eTMF and SMF (Paper TMF)
• To competently process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs and regulations, where applicable
• To complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
• To maintain study files as per study and/or client requirements or in accordance with ICON SOPs and applicable regulations.
• To complete departmental projects as assigned in accordance with specified timelines, ICON SOPs and regulations
• To maintain document record and filing supplies ensuring adequate supplies are available to Document Management staff
• Recognize, exemplify and adhere to ICON's values which centers around commitment to People, Clients and Performance. 

Niramay Drug Agency

 Pharmacist (2016—2018)

Advance Care Group, UAE

Clinical Pharmacist (2018 – 2023)

• Maintain the pharmacy as per DHA Guideline
• Responsible for Inventory, Stock and Monthly Countability
• E-claim submission, Insurance submission

• PG Diploma (2022—2023, one year), Global Institute of Clinical Research
• Clinical Trial Management 
• 84%, Grade A+
• MBA (2020—2022),  MGAHV (Central University of Wardha, Maharashtra)
• Marketing & Finance
• 83%, First Division
• B. Pharmacy (2009-2013), SRM University, Chennai
•  70%, CGPA
• CERTIFICATION

Clinical Research

• Clinical Trial Operation, (Johns Hopkins University)
• Data management for clinical Research (Vanderbilt University)
• Design & Interpretation in Clinical Research, (Jhons Hopkins University)
• ICH-GCP & GMP, (Quest Life Sciences)

Project Management

• Google Project Management,(Google)
• Diploma in Project Management , (Alison)
• Scrum Master Certification, (Learn Quest) 
• Agile leadership,(University of Colorado)

Business Management

• Brand Management & behavior, (University of London)
• Risk Management,(International Business Management Institute)
• Product Analytics Certification, PAC ,(Mixpanel)
• Business Process Analyst,(Airslate Academy)

License & Certification

• PMI-CAPM, (Project Management Institute )
• Lean Six Sigma, Green Belt (LSSGB), (IMC-Dubai)
• ISO-9001-2015 QMS, (IR Classes)
• ICH-GCP (NIDA), (NIDA Clinical Trial Network)
• DHA (Clinical Pharmacist), (Dubai Health Authority)
• Tableau Software,(Intellipat)
• UAE Driving License, (RTA, Dubai)
• CPD Certification