Virtual Trial Study Leads (VTSL) are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster.
The VTSL is an essential member of the core project team leading the team and responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.
Virtual Trial Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction.
VTSLs run their own studies. The VTSL focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers.
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 Virtual Trials studies.
Understand project strategy and operationalize the agreed upon approach.
Train both VTS and Traditional teams on the processes, capabilities and structure of the VTS organization.
Develop and / or support on the preparation of integrated study management plans in collaboration with the VTS and traditional project teams.
Accountable for the strategic development and execution or delivery of VTS 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 primary project oversight and / or contact with customers and own relationship with the project’s key customer contact(s)
Communicate / collaborate with IQVIA business development representatives as necessary.
Set objectives for the core 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 traditional study team, to support milestone achievement and to 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.
May participate in executive committees as part of program leadership.
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.
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.
REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Typically requires 3 - 5 years of prior relevant experience, preferably in the Virtual / decentralized trial environment.
Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
Typically viewed as having a specialty within discipline.
Bachelor's Degree Life sciences or related field.
Additional Work Experience
Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
Requires 7 years clinical research experience including 4 years of project management experience or equivalent combination of education, training and experience.
Skills and Abilities
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.
Good understanding of the competitive environment and how to communicate / demonstrate value through IQVIA solutions.
Communication - Strong written and verbal communication skills including good command of
Strong presentation skills.
Requires strong negotiation and customer management skills.
Problem solving - Strong problem-solving skills.
Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring / managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
Organization - Planning, time management and prioritization skills Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
Prioritization - Ability to handle conflicting priorities.
Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project.
Quality - Attention to detail and accuracy in work.
Quality - Results-oriented approach to work delivery and output. Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
Collaboration - Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Excellent customer service skills and demonstrated ability to understand customer needs.
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences
Good understanding of other IQVIA functions and their inter-relationship with Project Leadership.
Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
Additional Skills and Abilities
IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, Innovation and Ownership).