Solution Implementation Manager USA, India, UK

Software Implementation Management

• Apply consultative approach in understanding customer requirements for the scope of implementation; provide necessary documentation for the solution Implementation; and, carry out successful implementation utilizing effective project management techniques and quality compliance.
• Apply software development principles, concepts and techniques with a focus on business functionality and application configuration to produce deliverables for implementations.
• Interface directly with technical peers at various customer sites during the client implementation.
• Work closely with external customer project teams, internal implementation teams, core development, validation, quality assurance, operations and customer care to provide Root Cause Analysis and fixes for defects found during all testing phases (e.g., UAT) and production deployment.
• Perform training and knowledge transfer to the support organization for new client implementations.
• Responsible to test the software with a focus to find bugs. It involves enhancing the usability of the software and reducing the risk of ‘defects’ being found in the software delivered.
• Based on business needsyou may be assigned roles with respective to your department other than the above mentioned roles.
• Build and manage effective software implementation teams.

Implementation Operations Management

• Manage the day to day operations of the CTRenaissance product working with Implementation Team, Project Strategy, Delivery
• Management, R&D and Customer Care department heads to ensure optimal operations and integrated efforts. Staff may include solution architect, implementation consultant, validation consultant, solution training executives, and quality executives.
• Develop and implement department SOPs, Computer Systems Validation Working Practice Guides to assure regulatory compliance and good clinical practices, which may include the application call flow, user interface rules, and management of the data and electronic records. The Validation Working Practice Guide may outline key components such as Validation protocol, summary, and basic script writing.
• Define and manage a CTRenaissance Implementation standard package, which may include standard document templates, implementation guide, standard roles & responsibilities, quality compliance check-list etc.
• Work with the software R&D and hosting vendors in discussing software issues or new customizations/enhancements and carry out necessary upgrades in successive release plans.Create and track these issues using their internal ticket system.
• Identify, create, implement, and track implementation project key milestones through use of MS Project.
• Conduct daily/weekly meetings with internal implementation teams, R&D team, as well as the customer stakeholders to review status, identify any obstacles, and provide status across departments and upper management.This also includes documenting all implementation progress, enhancement requests, configuration defects through use of the defect/requirements tracking tool JAMA.
• Develop and provide monthly to senior management key implementation metrics throughout the year and historically.Metrics include average duration of standard implementations; data loads frequencies, implementation success rate, key performance indicators.
• Quality performance metrics include number of c onfiguration defects found during validation and production deviations found.
• Identify gaps and provide solutions in the software development life cycle processes, User and Functional documentation, and software validation practices.
• Develop User and Functional requirements for the CTRenaissance product in conjunction with a Business Analyst.
• Ensure highest standards of data integrity, utilizing data/process checks and QA; identifies and implements appropriate training program in conjunction with IT and Customer Care.

Solution Implementation Compliance Management

• Carry out and manage validation of all customer implementation based on 21 CFR Part 11 guidelines and effective computer systems validation methodology

Client Relationship Management, Business Development Support

• Support business development in pre-sales engineering, proposal development, proposal defense, client presentations, and providing solution to client needs.
• Plans, negotiates/recruits, and manages external partnerships, alliances, collaborators, contractors, CROs, and FSPs for MaxisIT as necessary.
• Attend conferences as a presenter and assist in client meetings
• Conduct webinars, talking about MaxisIT solutions and customer case studies

Skills:

• 5-10 years experience in the Pharma/Life Science/Biotech industry preferably related to clinical research and development
• Excellent written and oral communications skills.
• Exceptional ability and initiative to learn and research new concepts, ideas, and technologies quickly.
• Exceptional systems/process orientation with demonstrated analytical thinking, organization skills and problem solving skills.
• Ability to quickly pick up new tools and technologies.
• Willingness and ability to train and teach others.
• Ability to facilitate meetings and follow up with resulting action items.
• Ability to prioritize and execute tasks in a high-pressure environment.
• Excellent presentation and interpersonal skills.
• Ability to work effectively in a multi-cultural environment, and to lead and influence cross-organizationally with and without direct authority.
• Ability to effectively move forward on tasks even with ambiguous or changing requirements.
• Ability to communicate ideas in both technical and user-friendly language.
• Ability to work in a team-oriented, collaborative environment.