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 Operations Director

Responsibilities:

• Provide Clinical expertise to project team as needed
• Provide Clinical Management Oversight of clinical projects to ensure consistent on-time completion of client deliverables and timely escalation and resolution of issues.
• Collaborate with other department and/or functional groups to ensure consistency of processes.
• Assess training requirements for monitoring staff and organize appropriate training 
• Provides staff with expert clinical research and therapeutic advice. 
• Maintain awareness of overall development in the field of clinical research 
• Manage multiple priorities within the department and across staff. 
• Participate in the development of the clinical portion of client proposals including preparation of clinical project budget and text. 
• Preparation for and attendance at capabilities and bid defense meetings. 
• Participate in marketing activities, client presentations, and proposal development. 
• Participate in and attend professional and industry meetings as a representative
• Oversee selection and management of all clinical vendors with focus on efficiency and deliverables
• Serve as escalation point of contact for all clinical management and vendor management issues 
• Support Clinical Affairs in the development and review of the protocol/study design, case report forms, informed consent forms and other documents 
• Oversee the study managers development and approval of clinical study execution plans, including site selection and activation and tools including data capture instruments and the trial master file
• Use objective performance indicators to ensure quality and validity of clinical data outputs from all trials 

Qualifications:

• 10-15+ years' experience in clinical trial management 
• Thorough knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management. 
• Experience with complex trials
• Understanding of either drug development or experience with device development strongly preferred
• Demonstrated track record of successfully supporting, developing and executing clinical development plans
• Strong communication skills (verbal and written) to express complex ideas. 
• Excellent organizational and interpersonal skills. 
• Positive attitude and ability to interact with all levels of staff. 
• Ability to protect confidential/sensitive information. 

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.