Clinical Systems Project Manager
Multiple Locations: Raleigh, NC, USA • United States
Requisition Number: 5553
Position Title: Clinical Systems Project Manager
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
SUMMARY: Applies both business knowledge and technical expertise to support the implementation of clinical systems for business stakeholders to meet cross-organizational business needs as well as the configuration of systems to meet study requirements by providing analysis, recommendation, documentation, and delivery of technical solutions.
Tasks may include but are not limited to:
- Provide technical input to multi-disciplined project teams tasked by senior executives to address particular business needs during all project phases from discovery to retirement
- Provide analysis input, technical documentation, and other support needed to build a business case for strategic initiatives supporting departments across the corporation
- Apply both business as well as technical expertise to assist in the selection and implementation of external systems and services
- Provide technical support to drive adoption of new solutions
- Produce and maintain business requirement, configuration requirement, and technical specification documentation for clinical systems as well as for study-specific software implementations or configurations, such as IRT or cross-system integrations
- Elicit stakeholders’ underlying business needs and transform them into documented business requirements, via multiple and various techniques including: interviewing stakeholders and users, applying business knowledge and insight, researching industry best practices and emerging technology, and considering options beyond stakeholders’ suggested solutions
- Manage the requirements change process to ensure traceability and in alignment with departmental processes and tools
- Ensure effective communication of business and functional requirements to the project team and stakeholders
- Provide expertise and mentorship to the project team and stakeholders in the use of new systems
- Configure systems and integrations between systems to meet the needs of documented requirements at a system or study level, in alignment with relevant SOPs and work practices
- Provide quality control review of configurations implemented by others to verify alignment with SOPs and requirements
- Support or execute the design, implementation, and quality control review of reports using business intelligence tools
- Perform other duties as assigned
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Ability to communicate concisely and effectively in both written and spoken English
- Proficient in the use of common office software
- Highly effective in the use of interviews to uncover fundamental business requirements
- Strong presentation skills
- Able to work with all levels of stakeholders including senior executives
- Ability to quickly become proficient in new systems, including the ability to represent system capabilities via demonstration
- Self-motivated individual who can positively contribute to a team environment
- High attention to detail
- Highly creative, and able to adapt to new technologies, concepts and processes, and to make improvements and solve problems
- Ability to mentor others in new technologies and best practices
- Educated to degree level in a relevant discipline or able to demonstrate equivalent work experience
- Experience of analysing user or business requirements and documenting them
- Experience with various modelling techniques such as process modeling, data modeling, system modeling
- 5+ years’ experience in the conduct of clinical trials and an understanding of the computer systems utilized in support of clinical trials OR in business systems analysis for medium to large back office systems
- Understanding of application and integration infrastructures and how they can and should be utilized to achieve business goals
- Familiarity with user experience concepts and best practices
- Familiarity with risk assessment and mitigation planning strategies
- Familiarity with GxP regulatory requirements
- Understanding of IRT design and just-in-time drug supply desired
- Familiarity with clinical trials, patient safety, data integrity and associated regulations desired
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Employment Type: Regular
Community / Marketing Title: Clinical Systems Project Manager
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Raleigh, North Carolina US
CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.