Local Trial Manager (Sponsor Dedicated)

IQVIA; Durham (NC); On-site; USD 68,400 - 232,800; Full time

Job summary

IQVIA is seeking an Associate Project Lead (Local Trial Manager) to join our Durham, NC clinical delivery team. You will collaborate with clinical and functional teams to drive study execution under SOPs, delivering quality results and client satisfaction.

The role requires a Bachelor's in life sciences and at least 2 years of clinical trial management experience, with strong communication skills and proficiency in MS Office.

Qualifications

• Bachelors degree in life sciences or related field is required.
• Minimum 2 years clinical research experience in project or trial management.
• Solid understanding of clinical trials and ICH GCP guidelines.
• Strong written and verbal English communication and presentation skills.
• Good problem solving, planning and prioritization abilities.
• Experience coordinating with cross-functional teams and clients.
• Familiarity with study financials and change control processes.

Responsibilities

• Develop integrated study management plans with core project teams.
• Lead assigned portion of studies ensuring speed, quality and cost targets.
• Set objectives for sub-teams and monitor performance.
• Collaborate with other functions to meet milestones and resolve issues.
• Provide risk management input and support contingency planning.
• Ensure quality by addressing risks and implementing corrective actions.
• May serve as primary or backup contact for customers.
• Support project leader in vendor management and change control.
• Forecast opportunities to accelerate activities and revenue.

Skills

Project management

Communication skills

Problem solving

Organization

Time management

Collaboration

Cross-cultural awareness

Client focus

Education

Bachelor's Degree in life sciences

Tools

MS Office

Job description

Job Overview

Associate Project Leads (Local Trial Managers) 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 Associate Project Lead 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. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. The Associate Project Lead support the efforts of CPM to drive operational excellence and strategic leadership with our customers. Associate Project Leads may run their own studies, as part of their development.

Essential Functions

• Provide input in to the development of integrated study management plans with the core project team and/or sub-team.
• Accountable for assigned portion of clinical studies as per the contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of project sub-team(s), according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to internal stakeholders. Support the project leader to prepare/present project and/or sub-team information proactively to external stakeholders.
• Identify risk (positive and negative) and contingencies and partner with project leader in problem solving and resolution efforts.
• 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.
• May serve as primary (for small projects) or back-up project contact with customer.
• 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.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements

Qualifications

• Bachelor's Degree In life sciences or related field required Req
• 2 years clinical research experience in project management or trial management
• Requires intermediate level knowledge of principles, theories, and concepts of a job area, 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.;
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving - Strong problem solving skills.
• 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.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• 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 coworkers, managers and clients. Strong customer service skills.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Finances - Good understanding of project financials.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

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

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $68,400.00 - $232,800.00. 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.