The Global Trial Manager (GTM) -within Clinical Functional Service Partnerships Clinical FSP business unit- is assigned to one sponsor and is focused on the delivery and quality of the contracted Clinical services to achieve the customer satisfaction.
Focus is on leveraging clinical operations and therapeutic expertise along with the diverse IQVIA solutions to drive operational excellence particularly in respect to subject / patient recruitment and on-time high quality data collection.
The GTM provides leadership of the clinical team to achieve the delivery of the projects overall objectives to the Sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our SOPs, policies and practices.
Accountable for ensuring the right subjects and right data to meet our contractual requirements.
Participate in bid defense preparations. Attend bid defense presentations and lead the clinical delivery strategy for medium size and multiple country / region studies, in partnership with business development as needed.
Develop and maintain clinical project plans, including but not limited to clinical operations plan, recruitment and retention strategy plan, etc.
to be incorporated into the integrated study management plan / project management plan.
Accountable for the clinical delivery (subject recruitment, site management, data integrity) per contract, ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Partner with the leaders to confirm objectives of the clinical team according to agreed-upon contract, strategy and approach.
Effectively communicate and assess performance against these agreed objectives.
Ensure all appropriate subject / patient recruitment strategies are in place at the outset of the study to maximize subject / patient recruitment opportunities to achieve delivery according to contract, including, but not limited to, all outreach or digital offerings being explored and deployed.
Monitor clinical progress against contract and prepare / present project information proactively to all stakeholders internally and externally as required.
Deliver the project / program according to the quality management plan. Guide CRAs and advise on critical specific study issues.
Collaborate with other functional groups within the sponsor where necessary to support milestone achievement and to manage study issues and obstacles.
Manage risks (positive and negative) which could impact on the clinical delivery of the project and determine contingencies.
Partner with functional leaders in problem solving and resolution efforts.
Adopt corporate initiatives and changes and serve as a change advocate when necessary.
Ideal Background : Education :
Advanced degree or equivalent education / degree in life science / healthcare recommended.
7 years clinical research / monitoring experience; or equivalent combination of education, training and experience.
At least 2-3 years leading clinical research studies (regional and / or globally speaking) . Involvement in cross-functional, multicultural and international clinical trials;
demonstrated capabilities in supporting operational aspects of clinical trial related activities.
Skills & abilities :
Broad protocol knowledge.
Strong software and computer skills, including MS Office applications
Client Focus : excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal / external stakeholders and with the customer, and negotiate solutions.
Strong communication skills.
Leading & Directing
Deciding and Initiating Action
Planning and Organizing
Coping with Pressure & Setback
Project Centric Delivery
Fluent English (oral and written). Mandatory.
Job dimensions :
Should be based on Buenos Aires, Argentina.
Individual Contributor role (no direct reports).
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world.
The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.