General Scope and Summary
The Consultant, Clinical Systems will serve as an expert resource, collaborating with Clinical Operations, Information Technologies and Quality Systems in the selection, implementation and maintenance of applications. This role is responsible for hands-on management of the clinical systems while also contributing to the development of the clinical systems strategy.
Roles and Responsibilities
- Contribute to Sage’s electronic clinical systems strategy to support trial execution and oversight in an outsourced development model.
- Oversee the strategy, management and integration of one or more electronic systems, including vendors and technology. This will involve hands-on participation in the configuration and maintenance of the system(s).
- Partner with external service providers.
- Consult with Clinical Operations to evaluate and outline the evolving data storage and reporting needs.
- Liaise with external vendors to define data exchange processes.
- Oversee the transfer and incorporation of clinical trial operational data.
- Analyze business processes, propose solutions for current and future needs, and assist in implementing recommended improvements, in accordance with Sage operating standards.
- Assure system is properly implemented and operated to achieve and maintain GxP validation, including execution of testing, and participating in change management and related processes.
- In partnership with IT and QA, develop and manage system documentation including, but not limited to, system specifications, SOPs and training plans.
- Collaborate with users to establish operational work flows and create and provide user training.
- Develop outputs of operational data for reporting of metrics and tracking progress.
- Create and customize program- and department-level analytical reports and dashboards to support a data-driven operating model.
- Support ad-hoc analytical projects.
- Develop and maintain internal data repositories, as needed.
- Drive innovation and the delivery of continuous process improvement.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Bachelor degree required (scientific or technical discipline), post-graduate degree preferred.
- 6 years of experience working in the clinical environment managing clinical systems (for example, EDC, IRT, eTMF, CTMS, clinical data warehouses), underlying processes, and data.
- 8 years of experience in pharmaceutical/biotechnology and extensive knowledge of ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content.
- Experience in developing business specifications/requirements and user acceptance testing for computer systems.
- Experience with vendor management and oversight of data exchange, migration and integration.
- Demonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and to drive projects to consistently meet deadlines.
- Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects, both working independently and within a team.
- Flexibility to adapt to the dynamic needs of a growing biotech company and to manage change effectively.
- Ability to learn quickly and adjust approach to problems based on feedback.
- Demonstrated experience working in a matrix environment.
- Strong team player that has a customer service approach and is solution oriented.
- PC literacy required, including fluid use of common MS applications.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of SAGE.