MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion

Sr. Clinical Data Analyst

• Assume the ability to meet the requirements of a CDAwith a high degree of proficiency and autonomy.

• Take responsibility for specific tasks on projects, oracts as the main point

 of contact for allthe DM deliverables on individual projects.

• Train team members on selected tasks.

• Develop CRFs, Data Management Plan, eCRF fillinginstructions.

• Develop project specific guidelines, e.g. SAE handling,Medical Coding, Third Party data handling and Universal ruling guide linesdocuments.

• Develop Edit Checks document.

• Lead UAT activities of Screen Testing & Edit Checkstesting.

• Lead Data validation and Query Management.

• Identifying and reporting protocol deviations andviolations.

• Conduct reconciliation of SAEs, send out queries asrequired and notify relevant Safety Groups of possible issues for their action.

• If required liaise with 3rd party vendors to cleanelectronic data.

• Perform Interim and final database QC activities.

•  Update allrelevant tracking system on an ongoing basis

MakroCare | A MakroGroup Company | www.MakroCare.com

MakroCare is an Expert Strategic Development andCommercialization Global Partner for Pharmaceutical, Biotechnology and MedicalDevice industries. Our Experience, Programs and Processes bring a New Dimensionto Development Strategy, Regulatory/Risk Planning & Management, ClinicalResearch, Medical/Scientific Support and Emerging Region Expansion.

MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS),ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)

MakroCare Awarded as:

•             BestBiopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma

•             BestPharmaceutical Strategic Development Specialist - UK Enterprises

•             TheOutstanding Consulting Firm - Insights Success

•             AIExcellence in Regulatory & Automation Solutions - Acquisition International

•             AIExcellence in Best Bio Pharma Development Partner - Acquisition International

•             BestPractices Award - Clinical Informatics

•             NJ Excellence Award - US Institute forExcellence in Commerce

•             BestBiotech Award - US Commerce Association

•            Clinical Research Team and Best Technological Development in ClinicalTrials Finalists - Scrip Awards

•             Circle Of Excellence – MerchantCircle

About MakroGroup | www.MakroGrp.com

Makro Group of Organizations established in 1996, Makroprovides a complete range of solutions for every stage of business andinformation lifecycle.

•            MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies

•             DDiAwarded by Insights Success, CIO, Corporate LiveWire, Pharma Tech Outlook,Clinical Informatics & SCRIP

•            MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company& TOP 100 diversity business in NJ

•            MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSRInitiative, has counseled over 3000 people.