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.