Clinical Project Manager managing clinical studies to deliver new drugs faster at IQVIA. Collaborating with teams to optimize project delivery with a focus on quality and financial success.
Responsibilities
Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
May be responsible for delivery and management of smaller, less complex, regional studies.
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.
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.
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.
May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate with IQVIA business development representatives, as necessary.
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.
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.
May be assigned 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.
Support staff development and mentor less experienced project team members on assigned projects to support their professional development.
Requirements
Bachelor's Degree Life sciences or related field
5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience.
Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience.
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.
Strong written and verbal communication skills including good command of English language.
Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
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.
Ability to handle conflicting priorities.
Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
Good understanding of project financials including experience managing, contractual obligations and implications.
Clinical Operations Director overseeing patient care in Oncology Clinics at Duke Health. Leading clinical management and strategic planning for Wake County Oncology Clinics.
Clinical Operations Manager overseeing clinical operations and trial execution at Novo Nordisk. Driving team performance and collaborating with global project teams in the Czech Republic.
Senior Clinical Project Manager at AstraZeneca leading clinical trial teams for clinical studies execution. Focusing on objectives and collaboration with stakeholders for quality and efficiency in processes.
Werkstudent in klinischer Forschung für Alcedis, Unterstützung in der Durchführung klinischer Studien. Praktische Erfahrung in einem modernen Umfeld mit flexiblem Stundenplan.
Executive Director, Clinical Operations at Summit Therapeutics leading global Phase III oncology clinical trials. Accountable for clinical trial delivery and managing a high - performing Clinical Operations organization.
Executive Director leading global execution of multiple Phase III clinical trials in oncology at Summit Therapeutics. Building and mentoring a high - performing Clinical Operations organization within a fast - paced biotech startup.
Project Assistant supporting the Clinical Operations department in the organization and execution of clinical studies. Involves collaboration with study centers and training investigators primarily in Germany.
Director of Clinical Operations overseeing phase 1 - 3 clinical trials in oncology at Summit Therapeutics. Responsible for managing cross - functional teams and ensuring compliance with regulations.
Director of Clinical Operations at Summit Therapeutics managing clinical trials and study execution for oncology. Responsible for overseeing vendor relations, budget management, and adherence to regulations.
Innovation Leader for Johnson & Johnson focusing on clinical trial innovation and project execution. Collaborating with multidisciplinary teams to enhance patient experiences and operational efficiency.