The virtual trials operations lead is responsible for implementation of decentralized trials (DCT) by leading clinical and study teams to achieve seamless management and execution. The lead will partner with study teams to set the strategy for effective operational management and regulatory compliance of DCT. This role will implement and iterate on the global infrastructure and partner ecosystem to enable end-to-end quality delivery of DCT. The role will also have responsibility for blending technology enabled delivery and the optimized business processes to maximize value to patients, investigators and customers. This role can be home or office based within the EMEA region.
Essential Job Duties
- Partner with the Head of Virtual Trial Operations to lead the implementation and refinement of the DCT delivery process
- Confirm, execute and evolve regulatory guidance on implementation of DCTs globally
- Lead implementation of the operational strategy within study teams to drive broader adoption of virtual trials
- Partner with Head, Virtual Trials to assess and evolve the DCT operational model using key success criteria to drive improved patient and site experience
- Responsible for identifying efficiency improvements within clinical operations, including revisions to SOPs and business processes. Drive implementation of risk evaluation and mitigation processes for DCTs in partnership with project teams.
- Leverage and assess the global partner ecosystem enabling DCTs. Identify gaps in partner network and support assessment of potential partners to enable end to end delivery of trial assessments and patient facing services remote from research sites.
- Support RFP process and customer engagements and ensure development of optimal delivery solutions are customized to study design and protocol
- Implement and identify improvements in end-to-end DCT operating plan for ensuring quality delivery and appropriate project management and oversight
- Implement and refine KPIs to support execution of DCTs and partner with product development teams to develop predictive and proactive risk detection and management
- Build and maintain positive team-based culture
Education/Qualifications
Bachelor’s degree in a health care or other scientific discipline or educational equivalent; Master’s degree or other advanced training in scientific or a healthcare field preferred
- Patient centric and results-oriented working with tenacity to advance projects and deliver on pre-determined milestone
- Highly intelligent and detail-oriented with an ability to think strategically and operationally on a wide range of issues in a solutions-oriented manner
- High tolerance for ambiguity and excellent clinical development judgement. Must be able to drive and influence decision making in a rapidly changing business context.
- Must have a results-oriented work ethic and a positive, can-do attitude. Must be willing and able to be «hands on» and willing to «roll-up sleeves» and delve into details
- Demonstrated ability to establish relationships with internal colleagues and external collaborators (e.g., investigators, KOL’s, vendor partners ) and represent the company in public (e.g., scientific conferences, partners).
- Demonstrated ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach
- Influence without authority skills: Educate and influence stakeholders to adopt DCT model and to add value to strategic business planning and decision-making
- Must be science-and data-driven
- Professional attitude, maturity, confidence, and credibility to advise and influence senior management
- Experience working and delivering in a cross-functional team and supporting new product development
- Strong knowledge of process development and optimization
- Strong business acumen.
- Ability to work in a collaborative culture where the best ideas win regardless of their origin.
- Persuasive, humble, inclusive, and resilient with a strong sense of urgency and entrepreneurial attitude.
Experience:
Wealth of clinical trials operations experience including experience in a study team leadership capacity. Must have excellent knowledge of clinical study operations.
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