Pratik Shelar

Pratik Shelar Email and Phone Number

Sr. Clinical Data Specialist @ Fortrea
Mumbai, MH, IN
Pratik Shelar's Location
Mumbai, Maharashtra, India, India
Pratik Shelar's Contact Details

Pratik Shelar personal email

About Pratik Shelar

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

Pratik Shelar's Current Company Details
Fortrea

Fortrea

View
Sr. Clinical Data Specialist
Mumbai, MH, IN
Website:
fortrea.com
Employees:
11102
Pratik Shelar Work Experience Details
  • Fortrea
    Sr. Clinical Data Specialist
    Fortrea
    Mumbai, Mh, In
  • Tata Consultancy Services
    Clinical Data Manager
    Tata Consultancy Services Oct 2019 - Present
    Mumbai, 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.
  • Tata Consultancy Services
    Certified Process Trainer
    Tata Consultancy Services Jun 2019 - Oct 2019
    Mumbai, Maharashtra, India
  • Tata Consultancy Services
    Process Lead - Clinical Operations
    Tata Consultancy Services Oct 2018 - Oct 2019
    Mumbai, Maharashtra, India
    Clinical 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.
  • Halyard Health
    Territory Manager
    Halyard Health Jan 2018 - Sep 2018
    Mumbai Area, India
  • Smiths Medical
    Business Development Manager
    Smiths Medical Apr 2016 - Jan 2018
    Mumbai Area, India
    Responsible 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.
  • B. Braun Group
    Territory Sales Executive
    B. Braun Group Jun 2015 - Apr 2016
    Mumbai, Maharashtra, India
  • Fresenius Kabi
    Se
    Fresenius Kabi Dec 2013 - Jun 2015

Pratik Shelar Skills

Biotechnology Market Research Life Sciences Marketing Business Development Management Medical Devices Sales Pharmaceutical Industry Medical Equipment Microsoft Office Healthcare Account Management Sales Operations

Pratik Shelar Education Details

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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