Job Overview
Decentralized Clinical Trial Study Leads (DCTL) are an integral part of clinical trial delivery to improve patients’ lives and bring therapies to the market faster. The DCTL role requires strong project management skills, customer and site facing engagement experience, creativity/innovation and the ability to thrive in a dynamic setting.
The DCTL may oversee studiesranging from fully decentralized trials to hybrid studieswhich require liaising withtraditional project delivery teams. Critical to the success of DCT is the ability to collaborate across multiple teams and stakeholders including but not limited to technology & IT , mobile nursing, site support services, regulatory, site startup, etc. DCTL’s also follow established SOP and policies focused on project delivery, productivity and quality resulting in strong project financial performance and customer satisfaction.
Responsibilities
Essential Functions
•Accountable for the strategic development and delivery of DCT studies in line with agreed upon contracts while optimizing speed, quality and cost of delivery, ensuring consistent use of study tools and training materials and compliance with system updates, standard processes, policies and procedures.
•Serve as DCT project oversight and/or contact with customers and own relationship with the project’s key customer contact(s)
•Setobjectives for the DCT project team according to agreed upon contract, strategy and approach, effectively communicate and assess performance, providing feedback and leadership.
•Collaborate with other functional groups within the company where necessary, including the core study team, to develop and/or support the preparation of integrated study management plans, support milestone achievement and manage study issues and obstacles.
•Monitor progress against contract and prepare/present project information proactively to all stakeholders internally and externally.
•Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate risks.
•Achieve project quality by identifying and proactively managing quality risks and issues, responding to issues raised by project team members and /implementing appropriate corrective and preventative action plans.
•Ensure the financial success of the project including optimal management and assignment of resources to achieve project goals and profitability.
•Forecast and identify opportunities to accelerate activities to bring milestones and revenue forward and implement appropriate actions to achieve.
•Identify changes in scope and manage change control process, including securing customer agreement to financial and milestone updates as necessary.
•Identify and communicate lessons learned and best practices to promote continuous improvement.
Other Functions May Include
•Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for 100% Virtual studies or as a component of the larger team for integrated hybrid DCTs studies. Understand project strategy and operationalize the agreed upon approach.
•Adopt corporate initiatives and changes and serve as a change advocate when necessary.
•Provide input to line managers on their project team members’ performance relative to project tasks. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development.
•Educate and train other teams and partners on the processes, capabilities and structure of the DCT organization.
•Communicate/collaborate with IQVIA business development representatives as necessary.
•Mayparticipate in executive committees as part of program leadership.
Minimum Qualifications
• Bachelor's Degree Life sciences or related field Req
• Requires5 years relevant clinical research experience or equivalent combination of education, training and experience.
• Requires advanced knowledge of and experience implementing Project Management methodologies, ideally within the clinical research space.
• Broad knowledge of DCT(current challenges and opportunities to improve clinical trial delivery) and other related job areas, typically obtained through advanced education combined with experience.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic knowledge desired.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).
Preferred Qualifications
• Technology Savvy – You have an affinity for learning and leveragingtechnology. Prior experience with set up or implementation of new platform/systems is a plus.
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation, negotiation and customer management skills.
• Problem solving - Strong problem-solving skillsability to quickly identify issues and escalate as necessary.
• Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.
• Leadership - Ability to work through others to deliver results