Site Activation Manager (Regulatory & Start-Up) at IQVIA

JOB DESCRIPTION

The Site Activation Manager (SAM) position within GSA team in IQVIA is our project manager for the start-up phase in charge of design and implementation of our strategy towards sites activation from award until open to enrolment. The SAM leads and oversees our country operations teams ensuring that our client commitments are delivered timely and according to project scope and processes. Additionally, for the assigned projects, the SAM represents the country site activation operations team to our internal project members and clients. The key project team members that the SAM interacts are the project manager, the clinical lead, a regulatory and contract and budget solution advisors and the country regulatory specialists. The SAM also counts on a rich regulatory intelligence database and best in class systems to enable the start up strategy execution.
The SAM is a fundamental role to deliver our clinical trial portfolio and belongs to a global unit with vast career growth opportunities.

Typical day to day includes working on 1-2 projects or a same client program performing the following activities:

• Participation of pre award and bid defense meeting activities providing start up expertise input for the project strategy.
• Upon award, develop the site activation delivery strategy according to project scope and specifics, indicating the activation projection for sites in diverse countries, site identification, regulatory, contract and start up elements’ timelines.
• Oversee the execution of site activation strategy, focusing in delivering sites in the agreed timeline, budget and within scope, pro-actively identifying and addressing risks.
• Communication with client, project team members and local regulatory specialists on study sites status, activation projections, risks, and opportunities to secure the activation strategy.
• Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans with project specific information.

Required Knowledge, Skills and Abilities

• B Sc Degree in Life Sciences or related field
• 5 - 7 years of proven experience managing projects in a scientific or clinical environment.
• Experience in an international environment preferred.
• Requires experience in leading projects in a cross-functional team.
• Strong leadership competencies to lead projects and multi-cultural teams.
• Project ownership controlling delivery on time, within scope and controlling budget.
• Demonstrable experience working on multiple projects or clients balancing competing priorities.
• Strong communication skills with the ability to negotiated and challenge decisions.
• Good regulatory and technical writing skills.
• Excellent understanding of study financial management.
• Proven ability to work on multiple projects balancing competing priorities.
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
• Proven ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.