Pratik Shelar work email
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Pratik Shelar personal email
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I'm a competent Clinical Data Manager with an experience in the area of Study Data Management, Clinical Operations, Regulatory Submissions, Financial Disclosure Management, CSR co-ordination, Clinical Support.Analytical and logical approach to the clinical processes and hands-on experience of clinical systems like Medidata Rave, InForm 6.3, EAP, Labmatrix, PDMS, eTMF, VeevaVault, CTMS.eCRF Guidelines preparation, Analytical labs and vendor Management, PK and Biomarker Vendor data reconciliation with CRF, SAE-Conmeds reconciliation, Manual Review of Casebooks for PI sign off,, eTMF analysis, SOP preparations, Process Assessments and Validation, Veeva Vault COV proficient. US FDA Regulatory Submissions.Previously Territory Manager focused on promotions and product management of premium medical devices & equipments into Corporate & Govt. Institutions in Mumbai and Maharashtra region.Accomplishments- Achieved TCS Star Performer Award for year 2019/2021/2022, Special Initiative Award - 2021, On The Spot Award - 2021/2022.- Achieved Excellence & Achievement Award at Smiths Medical 2017 - Achieved FIRE (Fresenius Intelligence Recognition Excellence) awards for best performance in West India.- Stood first in the country for highest performance for products of Fresenius Kabi Ind. Pvt. Ltd. in 2014SkillSet- Leadership, Business Development, Creativity, Analytical Thinking- Veeva Vault COV, eTMF, IMMS, RIMS, SOP preparation, Clinical Operations
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Sr. Clinical Data SpecialistFortreaMumbai, Mh, In -
Clinical Data ManagerTata Consultancy Services Oct 2019 - PresentMumbai, Maharashtra, India• Data review, Lab QC, SAE, Scan reconciliation, Data archival, Protocol deviation etc. UAT Script writing, Autoquery validation, CCF preparation• Vendor Management, Partner CRO EAP Management, Data Transfer Agreement testing.• Data Metrics, Dataset reconciliation, PK-Biomarker reconciliation, AE-SAE-Conmeds Reconciliation.• Study Conduct Activities – Therapeutic Area – Oncology.• InForm 6.3, PDMS, External Alliance System (EAP), eTMF, Veeva Vault, Veeva CTMS, Power BI, Clinical PRISM, eTrack, RIMS, FDA Submissions etc.Query management. Lab LNR QC, Protocol deviation entry, DVS manual review. • Review CRF, Data listings and Clinical database adherence to Protocol, eCCG, DMP etc., Archival of study documents in Veeva eTMF. Site subject PDF QC process. Reconciliation and updating of eCRF Guidelines in accordance with protocol amendments. -
Certified Process TrainerTata Consultancy Services Jun 2019 - Oct 2019Mumbai, Maharashtra, India -
Process Lead - Clinical OperationsTata Consultancy Services Oct 2018 - Oct 2019Mumbai, Maharashtra, IndiaClinical operations & Regulatory affairs, ICH-GCP Practices, Hands on ofthe clincal systems like eTMF, Veeva Vault, CTMS, eTrack.Repository documentation. Clinical Data Management.Preparation of critical publishing documents of the clinical trials. (CSR)Financial disclosure monitoring and QA of the essential documents.Worked with global teams based in Belgium, Italy and U.S.Managed Site Activation process, CID Creation Activity. -
Territory ManagerHalyard Health Jan 2018 - Sep 2018Mumbai Area, India -
Business Development ManagerSmiths Medical Apr 2016 - Jan 2018Mumbai Area, IndiaResponsible for handling premium devices like Critical Care Airway Management, Respiratory & Anesthesia Portfolio.Enhancing healthcare personnel by conducting various hands-on workshops and giving presentations/demos to Paramedical staffs for betterment. -
Territory Sales ExecutiveB. Braun Group Jun 2015 - Apr 2016Mumbai, Maharashtra, India -
SeFresenius Kabi Dec 2013 - Jun 2015
Pratik Shelar Skills
Pratik Shelar Education Details
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Pillai'S Institute Of Management Studies & Research, New PanvelBiotechnology -
Biotechnology -
Vartak College, VasaiA
Frequently Asked Questions about Pratik Shelar
What company does Pratik Shelar work for?
Pratik Shelar works for Fortrea
What is Pratik Shelar's role at the current company?
Pratik Shelar's current role is Sr. Clinical Data Specialist.
What is Pratik Shelar's email address?
Pratik Shelar's email address is al****@****ail.com
What schools did Pratik Shelar attend?
Pratik Shelar attended University Of Mumbai, Pillai's Institute Of Management Studies & Research, New Panvel, University Of Mumbai, Vartak College, Vasai.
What are some of Pratik Shelar's interests?
Pratik Shelar has interest in New Technologies, Reading Biographies, Painting, Automotive Designing.
What skills is Pratik Shelar known for?
Pratik Shelar has skills like Biotechnology, Market Research, Life Sciences, Marketing, Business Development, Management, Medical Devices, Sales, Pharmaceutical Industry, Medical Equipment, Microsoft Office, Healthcare.
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Pratik Shelar
“Data Engineer | Expert In Big Data & Cloud Solutions | Optimizing Data Pipelines” “Data Engineer | Specializing In Etl, Sql, And Python | Enabling Data-Driven Decisions”Mumbai -
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Pratik Shelar
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