Karthik Sharma Kalathil, Associate Director, Service Management, Clinical IT

Karthik Sharma Kalathil

Associate Director, Service Management, Clinical IT

Syneos Health

Location
India - Hyderabad
Education
Bachelor's degree, Bachelor of Homoeopathic Medicine and Surgery
Experience
9 years, 4 Months

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Work Experience

Total years of experience :9 years, 4 Months

Associate Director, Service Management, Clinical IT at Syneos Health
  • India - Hyderabad
  • My current job since February 2015

Experience: ASQ Certified Clinical Research Expert offering 15+ years of formidable experience across the Healthcare IT industry with a strong background in process automation, Information Security, clinical research IT operations management, business development, client relationship management, project management, devising SOPs, process improvement, and audit management. Leverages expertise in requirements gathering, analysis, design, development, implementation, application testing, production deployment, support & code review. Experienced in Agile methodologies.

Core Competency: Profound experience in driving automation projects across clinical and corporate applications and delivering them on time with utmost quality. Adept at developing new processes and transitioning new application support and projects by correlating with various stakeholders & vendors. Carrying out integration-related activities in M&As (Mergers & Acquisitions). Enhancing SOX (Sarbanes-Oxley Act) compliance controls for a variety of applications & liaising as an application owner & executing internal, external, and regulatory audits. Managing onsite teams including The United States, Germany, and third-party vendors. Coordinating with the Project Leaders, Project Managers, CRAs, CRCs, Investigators, Pharmacists, Site Personnel in general across all stages of the clinical trial. Hands-on experience in Azure Active Directory and Saviynt Attestation Management. Actively travelling to onsite (The United States & Canada) to develop the business through negotiating, transitioning, and setting up teams from scratch in offshore locations.

Value Offered: Dexterous in leading various global IT & Clinical processes and ensuring that all the processes, SOPs, and OGs, comply with both the Regulatory, SOX & organizational regulations. Maneuvering various teams including Global Access Management Team (GAM), Identity and Access Management Team (IAM), Saviynt Identity Management, Azure Active Directory Management and Application Support Team. Deft at transitioning new applications & processes to the department and developing & implementing new processes from scratch. Initiating team meetings with the project team & client to ensure project objectives are met and to gather valuable insights from the client on resourcing, project goals, technical specifications, the scope of work, and timelines. Adept Vendor and Stakeholder management. Experience supporting Regulatory, External, Internal and SOX audits. Information Security Vulnerability issues.

Personal Attributes: Proficient in Global process management, Project management and executing clinical IT Support operations. Possess expertise in leading multifunctional teams and managing global processes for the company across various geographies. Experienced in Vendor and Stakeholder Management.

Global Exposure
Gained exposure to a global culture which includes managing direct reports in the United States, Germany and Canada in addition to India for various global processes and transitioning teams from scratch in offshore locations to inhouse and vendors.

Education

Bachelor's degree, Bachelor of Homoeopathic Medicine and Surgery
  • at Rajiv Gandhi University Of Health Sciences
  • June 2007

Health Sciences Graduate. Medical Graduate in Homeopathic Medicine.

Specialties & Skills

Information Security Management
Process Automation
IT Operations
Global Projects
process automation
Leadership
project management
Application Management
operations management
Life Sciences Technology
Information Security Vulnerability

Languages

English
Expert

Training and Certifications

Certified Lean Six Sigma Green Belt (Certificate)
Date Attended:
May 2018

Hobbies

  • Football, Travelling, cricket