As a member of the DTE Global Clinical Operations (GCO) team, the Business Consultant will be a key resource in ensuring the strategy, planning and delivery of key technology solutions in support of our Clinical Business Partners. The incumbent will partner with DTE and business leadership to develop Clinical Trial Business Capabilities and systems roadmaps that align to support business strategy. As an experienced member of the team, the incumbent will collaborate with stakeholders, vendors, and Managed Services Providers to ensure successful roadmap, scope, delivery and support of specific Business Capabilities.
Key Duties and Responsibilities:
Become a trusted partner of the business leaders
Take part in the lifecycle of Global Clinical Operations and Clinical Development technology solutions - defining business need, project planning, vendor selection, development, deployment, and end user adoption and provide ongoing management and functional oversight for all related systems.
Provide support in building an aligned vision for Global Clinical Operations and Clinical Development Data & Technology ecosystem.
Technology Solution Management - Understand the evolving needs of the business, appropriately prioritizes digital demands, and selects appropriate solutions, tools and platforms to be deployed.
Navigate a highly complex digital ecosystem in support of global trials, a variety of 3rd party providers, as well as GMDA partners, and delivers timely audit ready solution suggestions that can manage the volume and complexity required by the clinical development plan.
Measures and communicates business value, e.g. improved efficiency.
Proactively identifies and mitigates key cross-functional and vendor issues escalating to management as needed.
Understanding of the Clinical business areas, processes, and applicable regulatory environments In-depth and specialized knowledge in the core disciplines of Software Development Life Cycle (SDLC), project management, business analysis, and solution design/delivery
Exceptional written and verbal communication skills and ability to present in a clear and concise manner to audiences at all levels of an organization as well as system lifecycle expertise
Strong analytical, quantitative, problem-solving and prioritization skills including development of business case / value propositions
Customer focused, with ability to maintain an independent view.
Proven ability to interpret internal and external customer needs, negotiate and influence.
Excellent interpersonal skills, ability to develop relationships with key stakeholders, good conflict management and negotiation skills.
High degree of motivation - results oriented.
Proven experience in Global Clinical Operations and Clinical Development digital strategy generation in a complex business, demonstrating integration & alignment with multiple constituents, functional area strategies and objectives.
Knowledge and/or experience with broad array of Clinical systems including: Clinical Trials Management System (CTMS), Risk Based Study Monitoring (RBSM), Electronic Trial Master File (eTMF), Clinical Trial Site Feasibility and Transparency, Safety Letter Distribution, Electronic Data Capture (EDC), Clinical Studies Operational Data Warehouse & Analytics, Site Portal Engagement/Training and Resource Management etc.
Significant 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.
Demonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and to drive projects to consistently meet multiple project deadlines while mitigating risks.
Experience with Agile development or program management methodologies