Implementation Manager – EDC at Medidata Solutions, Korea
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.
Medidata Solutions is a global technology company that provides Software-as-a-Service solutions for clinical trials.
This position is located in Korea.
A Medidata Implementation Manager (IM) will ensure that Medidata’s software applications are implemented and configured in accordance with standard business processes, meet client requirements and adhere to Good Clinical Data Management Practices. The IM will have leadership and mentorship responsibilities of a supporting staff. The IM will be responsible for delivering to clients all assigned projects and tasks. The IM will work with Engagement Directors, Project Directors, Project Managers, and other functional departments during the implementation and configuration of Medidata’s software applications for clinical studies, and will assist in the training, education, and mentoring of colleagues who are new to working with clinical trials.
- Ensure that supporting staff are aligned and meet Project Management timelines and deliverables
- Provide mentorship to staff: Associate Implementation Consultants, Implementation Consultants,Senior Implementation Consultants, Project Managers, and others within Medidata
- Provide estimates on level of effort for various projects based on scope of work
- Assist in resource management, including identifying back-ups for AICs, ICs and Sr.ICs when out of office, assigning tasks and activities to ICs and Sr. ICs.
- Regularly provide feedback to team management regarding skills and coaching opportunities for AICs, ICs and Sr. ICs.
- Facilitate regular team meetings to share information and discuss issues
- Advise and provide consultation to customers and internal Medidata staff on bestpractices for implementing Medidata’s software
- Create and maintain project plan with respect to timelines, key deliverables, andplanning resources
- Work directly with the client to prepare, adapt, or agree on all specifications provided by the client
- Assist in the scheduling of professional services resources and ensure timely completion of deliverables
- Define and enforce data collection and handling standards on all deliverables to ensure consistency and facilitate downstream processing (e.g., QC testing)
- Coordinate and support developers during study development
- Author specifications based upon client requirements, including functional test cases,for use in configuring and developing solutions in Medidata’s suite of productsas well as in custom integrations with other products
- Configure Medidata software products to meet customer requirements
- Support training group in preparation of course materials and delivery of courses both internally and externally (e.g., clinical sites and investigator meetings) asneeded
- Support custom integrations to ensure final product meets customer requirements
- Support customer during user acceptance testing cycle by resolving issues, answering questions, and guiding them through the process
- Work with third party vendors such as central labs to ensure that all back-end clinical data changes follow best clinical data management practices
- Work with Quality Control department when needed on clinical software projects
- Provide written and verbal status reports to management on client projects and internal projects
- Comply with and enforce Medidata SOPs, procedures, and policies
- Participate and drive internal initiatives such as process improvements, product improvements, and identifying best practices
- Make recommendations and suggestions for new internal initiatives such as process improvements, product improvements, and identifying best practices
Desired Skills & Experience - Qualifications:
- 4 year undergraduate degree and 3years of experience working with clinical trials in a data management-related role, or equivalent combination of education and experience
- Knowledge of Clinical Trial processes,specifically as they relate to data collection, management, and preparation for statistical analysis
- Strong understanding data management plans/customer specifications for data entry screens, edit checks, custom reports and data integrations
- Ability to work with technical R&D staff and translate new software features into real world examples
- Ability to take responsibility for own actions as well as actions of staff
- Ability to lead and give direction based on department and company goals
- Ability to evaluate the skills of others and coach where gaps are identified
- Ability to perform effectively as part of a team and autonomously
- Knowledge of computer usage in a web-based environment
- Ability to think logically to solve complex problems
- Excellent verbal and written communication skills
- Solid analytical and technical skillswith regard to software applications
- Experience supporting project teams and meeting project timelines
- Excellent organizational and time management skills
- Strong collaboration and team-building skills
Please email resumes to Carolyn Dugan at firstname.lastname@example.org (reference: thekoreaguide.com)