Sandeep Patnamshetty
Hyderabad
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
12
12
years of professional experience
Work History
Sr Project Specialist
Syneos Health
6 2021 - Current
- Set-up, maintain and close out project files and study information ((e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems
- Maintain and distribute study-specific /financial reports (e.g
- Vendor/site invoices, investigator payments (grants and pass-through), forecasts, etc)
- May lead internal and external meetings as directed by the PL Prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings)
- Follows up with team members on action items to closure
- Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL
- Assesses and communicates KPIs for associated job tasks to PL with proposed action plan
- Prepares and provides status reports to customers with oversight from assigned PL Ensure all study documents are archived based on the appropriate guidelines and policy
- May serve as project representative for internal and external audits
- Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution actionable issues
- May serve as primary customer contact when PL is out of the office
- Seeks input from Project Director for customer support
- May mentor and train Project Specialists
Project Specialist
Syneos Health
10.2016 - 06.2021
- Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems
- Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings)
- Follows up with team members on action items to closure
- Maintains timely and effective communication among team members and site staff
- Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status
- May contact site staff as needed for critical information
- Provide administrative support to Project Leads and functional leads
- Ensure all study documents are archived based on the appropriate guidelines and policy
- Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.
Clinical Research Executive
QPS Bioserve CRO
11.2015 - 10.2016
- Writing, and compiling clinical study protocols and integrated clinical study reports
- As a project coordinator ensure completion of all Documents according to protocol ,SOP with applicable local requirements and FDA and ICH guidelines
- Ensure completion of adverse event records and subject safety and reporting to sponsor and IRB/IEC
- Logistics control for entire study (Investigator folders, E-CRF entry, Protocol training and delegation of study personnel, and updating project trackers on timely basis)
- Resolving quires during in process and retrospective audits reports
- Providing expert assistance in literature research
- Identification and development of clinical study designs as per current global customer requirements.
Senior Research Associate
Clinsync Clinical Reseach Organization
09.2012 - 10.2015
- With completeness of training of team regarding the GCP, monitoring plan, recording maintenance of essential documents & regulatory documents such as ethics Committee submission and other regulatory requirements
- Assisting study team for startup activities
- In-house monitoring as per monitoring plan in order to check & ensure compliance with study management, protocol GCP & other requirements
- Monitor study-related documentation ICD, Source Data CRF, Drug accountability logs to check & ensure the completeness & accuracy with compliance to protocol GCP, regulatory
- Identify and assist in reporting SAEs to sponsors and regulatory authorities coordinate in generating CRF data and all other activities with the clinical research team
- Reporting of study progress at regular intervals, to study principal investigator.
Education
Masters - Pharmacology -
Jawarharla Nehru Technology University - India
Licensed Pharmacist - Pharmaceutical Sciences - undefined
Jawaharlal Nehru Technology University - India
Skills
Therapeutic Experience
- Cardiovascular - Cardiovascular Disease
- Dermatology - Pruritus, Skin Disorders
- Endocrinology/Metabolism - Diabetes Mellitus
- Gastroenterology - Ulcer, Gastric
- Immunology / Inflammatory - IgA Nephropathy, Primary Immunodeficiency Disease
- Neurology - Seizure Disorders
- Oncology - Cancer, Hematologic Malignancies
- Respiratory - Respiratory Disorders
Affiliations
Jawarhal Nehru Technological University, 06/01/11
Biography
Sandeep Patnamshetty current position with Syneos Health is Sr Project Specialist within the Project Management Delivery Team. As a Sr Project Specialist, Mr Patnamshetty is responsible for maintaining and coordinating the logistical aspects of clinical projects and provides overall support to functional leads to ensure the successful completion of project deliverables. Sandeep supports the Project Lead (PL) to ensure the contracted services and expectations of assigned projects are carried out by the project teams in accordance with executed contracts and the customers requirements. Prior to Syneos Health, Mr. Sandeep Patnamshetty has relevant experience as senior CRA with 4 years of experience.
He has more than 10 years of experience in Clinical research working as Project Specialist, Clinical Research Executive and Sr. CRA managing Phase I to Phase IV studies across various therapeutic are as including Oncology, Cardiology, immunology, Gastroenterology , Endocrinology etc.
Currently Sandeep is working in Phase-II and III studies as project Specialist. He has received several awards and recognition for successful accomplishments of Projects in current and previous organization.
Sandeep is also experienced with Various clinical systems like M-CTMS,RAVE EDC, E-TMF,Veeva Imedidata,Trial Interactive,i Vault, SumTotal , Endpoint (IRT and IWRS), ERT, AgMednet, Trifecta, Clario, Transperfect (translations), clinsnow.
Languages
English - Speaking, Reading, Writing
Telugu - Speaking, Reading, Writing - Native
Hindi - Reading, Writing
Timeline
Project Specialist
Syneos Health
10.2016 - 06.2021
Clinical Research Executive
QPS Bioserve CRO
11.2015 - 10.2016
Senior Research Associate
Clinsync Clinical Reseach Organization
09.2012 - 10.2015
Sr Project Specialist
Syneos Health
6 2021 - Current
Masters - Pharmacology -
Jawarharla Nehru Technology University - India
Licensed Pharmacist - Pharmaceutical Sciences - undefined
Jawaharlal Nehru Technology University - India
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