Clinical Project Manager

JOB OVERVIEW

Job Profile Summary

Clinical Project Managers are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs (or Medical Devices) to the market faster. The Clinical Project Manager is an essential 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. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers.

Responsibilities

Essential Functions

• Prepare for and participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for multiple service, multiple country and/or multi regional studies. Understand project strategy and operationalise the agreed upon approach.

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International

Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements

(contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).

• Develop integrated study management plans with the core project team.

• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per 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.

• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.

• Set objectives of the core project team and/or 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

stakeholders internally and externally.

• Conduct regular team meetings and communicate appropriately to achieve objectives.

• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution

efforts.

• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team

and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.

• Serve as primary project contact with customer and own relationship with the project’s key customer contact(s). • Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.

• Ensure the financial success of the project.

• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at

Completion (EAC) and identify additional service opportunities or out of scope work.

• Forecast and identify opportunities to accelerate activities to bring revenue forward.

• Identify changes in scope and manage change control process as necessary.

• Identify lessons learned and implement best practices.

• Serve as the primary contact for vendors leading project vendor management and vendor

management related activities as per project requirements.

• Adopt corporate initiatives and changes and serve as a change advocate when necessary.

• Provide input to line managers of their project team members’ performance relative to project tasks.

• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.

• Support staff development and mentor less experienced project team members on assigned projects to

support their professional development.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience

Typically requires at least 3 years of relevant experience in the management of multi-country clinical trials within a CRO or pharmaceutical company environment, or equivalent experience in leading functional teams and/or in line (people) management roles.

Knowledge

Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.

Education

Education Level Education Details Req Pref Bachelor's Degree Life sciences

Skills and Abilities

Skill/Ability Description Proficiency

Knowledge of clinical trials - Knowledge of multicountry clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and EU CTR, EMA regulations and guidelines, towards

clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions.

Communication - Strong written and verbal communication skills including good command of English and Dutch language is a must. Strong presentation skills.

Leadership - Ability to work through others to deliver results to the appropriate quality and

timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.

Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.

Organisation - 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.

Prioritisation - Ability to handle conflicting priorities.

Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.

Quality - Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.

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 including experience managing,

contractual obligations and implications.

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

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.