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Job Id 349678
Title Clinical Data Manager
Job Type Permanent
City Hyderabad
State Telangana
Zip
Job Description

MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion


Clinical Data Manager
• Assume the ability to meet the requirements of a Manager with a high degree of proficiency and autonomy.
• Act as a study lead on complex or multiple projects.
• Manage all phases of data management activities from study start up to database close - Direct team members in daily activities
• Define and monitors metrics and modifies plan accordingly - Mentor project team members - If required, facilitate cross functional team meetings both internally and externally.
• Actively review and provide feedback on study productivity - Recognize out of scope activities and communicates to Group Head.
• Reviewing and providing inputs on CRFs (Unique and Expanded), Visit matrix doc and study specific Data Management Plan.
• Reviewing and providing inputs on project specific guidelines, e.g. SAE handling, Medical Coding, Third Party data handling and Universal ruling guide lines documents.
• Overall supervision of Screens UAT procedure and responsible for its documentation.
• Reviewing and providing inputs on Edit Checks document.
• Overall supervision of Edit Checks UAT procedure and responsible for its documentation.
• Reviewing and providing inputs on study specific eCRF filling instructions.
• Reviewing and providing inputs on Data Cleaning, Data Reconciliations and Data Quality.
• Requires minimal supervision by Manager
Apply knowledge across multiple projects - Define study specific processes - Identify inconsistencies and inefficiencies in processes and recommends solutions Skills - Excellent interpersonal, verbal and written communication skills.
•  Excellent computer skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, mPortal, IVRS, MS-Office products such as Excel, Word.
• Sound awareness of all relevant regulations, including GCP - Proses a thorough understanding of the various tasks related to project initiation, ongoing monitoring / processing and lock.
• Carefully weighs the priority of project tasks and directs team accordingly - Understands the strengths and development areas of team members.
• Ability to lead a -virtual-, global team as required - Gives others appropriate latitude to make decisions - Looks for win-win solutions to solve problems


MakroCare | A MakroGroup Company | www.MakroCare.com

MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, 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:
•             Best Biopharmaceutical Regulatory Consultancy Firm – Global Health & Pharma
•             Best Pharmaceutical Strategic Development Specialist - UK Enterprises
•             The Outstanding Consulting Firm - Insights Success
•             AI Excellence in Regulatory & Automation Solutions - Acquisition International
•             AI Excellence in Best Bio Pharma Development Partner - Acquisition International
•             Best Practices Award - Clinical Informatics
•             NJ Excellence Award - US Institute for Excellence in Commerce
•             Best Biotech Award - US Commerce Association
•             Clinical Research Team and Best Technological Development in Clinical Trials Finalists - Scrip Awards
•             Circle Of Excellence – MerchantCircle

About MakroGroup | www.MakroGrp.com

Makro Group of Organizations established in 1996, Makro provides a complete range of solutions for every stage of business and information lifecycle.

•             MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
•             DDi Awarded 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 CSR Initiative, has counseled over 3000 people.


Qualification
Experience 8-12 Years
Job Category Data Management
Posted On 12/10/2020
Expires On 2/10/2021
 
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