Local Trial Manager (Sponsor Dedicated)

IQVIA; Durham (NC); Sur place; USD 68 000 - 233 000; Plein temps

Résumé du poste

IQVIA is seeking a Local Trial Manager (Sponsor Dedicated) in Durham, NC to lead and manage clinical studies in collaboration with cross-functional teams. This role focuses on delivering study milestones on time, within budget, and in compliance with ICH-GCP and SOPs.

You will support the CPM and project leaders, oversee sub-teams, and work with external vendors as needed to ensure successful delivery and quality outcomes.

Qualifications

• Bachelor's Degree In life sciences or related field required.
• 2 years clinical research experience in project management or trial management.
• Knowledge of clinical trials conduct and regulatory requirements (ICH GCP).
• Strong written and verbal communication in English.
• Strong problem solving skills.
• Planning, time management and prioritization skills.
• MS Office proficiency: Word, Excel, PowerPoint.
• Ability to collaborate across teams and geographies.
• Understanding of project financials.

Responsabilités

• Provide input into the development of integrated study management plans with the core project team/sub-team.
• Accountable for assigned portion of clinical studies per contract while optimizing speed, quality and cost.
• Set objectives of project sub-team(s) and assess performance.
• Collaborate with other functional groups to support milestone achievement and to manage study issues.
• Monitor progress against contract and present project information to stakeholders.
• Identify risk and contingencies and partner with project leader in problem solving.
• Lead the efforts of a project sub-team and manage cross-collaboration.
• Support the project leader in ensuring financial success of the project.
• Forecast opportunities to accelerate activities and bring revenue forward.

Connaissances

Bachelor's degree

Clinical research

Communication

Problem solving

Organization

IT skills

Cross-collaboration

Financials

Formation

Bachelor's degree in life sciences

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

## Local Trial Manager (Sponsor Dedicated)Applylocations: Durham, North Carolina, United States of Americatime type: Full timeposted on: Posted Todayjob requisition id: R1560775Internal 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.comIQVIA 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/eoeIQVIA 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.