Local Trial Manager

Posted:
9/4/2024, 2:58:04 AM

Location(s):
North Carolina, United States ⋅ Boston, Massachusetts, United States ⋅ Durham, North Carolina, United States ⋅ Massachusetts, United States

Experience Level(s):
Senior

Field(s):
Business & Strategy

The Associate Clinical Project Manager/Local Trial Manager is a member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Project Leadership is focused on successful project delivery by applying a robust set of project management processes designed to enable productivity and quality resulting in strong financial performance and customer satisfaction.  

 

Your key purpose will be to drive operational excellence and strategic leadership as well as running your own small studies. 

 

Key collaborators are the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst for project coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up.  

 

This is an important and high-profile role within our Research and Development Clinical Operations organization and IQVIA’s size and global footprint will present you with the breadth of opportunities necessary to develop your career. 

 

Typically assigned to one or two projects, or a program, responsibilities might include: 

  • Provide input to integrated study management plans with the core project team and/or sub-team and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures 

  • Anticipating risk and implementing mitigation strategies for assigned activities and partner with project leader and other functional leads in problem solving and resolution efforts. 

  • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. 

  • Support the project leader to prepare/present project and/or sub-team information proactively to external stakeholders. 

  • Achieve project quality by identifying quality risks and issues, responding to issues raised by project sub-team members and partner with project leader planning/implementing appropriate corrective and preventative action plans. 

  • Lead the efforts of a project sub-team, responsible for managing cross-collaboration of the sub-team to support milestone achievement and to manage issues and obstacles. 

  • Support the project leader in ensuring the financial success of the project. 

  • Forecast and identify opportunities to accelerate activities to bring revenue forward in partnership with the senior project leader. 

  • Identify changes in scope and partner with project leader to manage change control process as necessary. 

  • When assigned as project vendor manager  

  • Develop the study level vendor management plan including deliverables & milestones, SLAs and reporting, Communication & Issue escalation plan, risks management, filing plan (eTMF), equipment supply strategy, vendor training, key team member transition plan, system access 

  • Serving as the primary contact with the customer for progress, risk management and governance of third-party vendors 

  • Manage & track vendor performance through KPIs, deliverables and milestones and prepare/present third party vendor status/ performance proactively to internal stakeholders 

  • Ensuring the third party vendor study budget is managed proactively including scope changes and financial systems are accurate 

  • May act as primary Project Leads in small, and simple studies or back-up project contact with customer
  • Set objectives of project sub-team(s), according to agreed upon contract, strategy and approach, effectively communicate and assess performance 
  • Monitor progress against contract and prepare/present project and/or sub-team information proactively to internal stakeholders

 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 

  • Bachelor's degree in life sciences or related field and 2 years’ clinical research experience  

  • Minimum 2-3 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience 

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $82,400.00 - $137,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.