Clinical Research Coordinator managing the conduct of clinical trials at Emory University. Handling administrative activities and overseeing research project requirements and compliance.
About the role
- Clinical Trial Manager overseeing clinical trials and delivering project management excellence. Working with the sponsor-dedicated team to enhance patient outcomes in the healthcare sector.
Responsibilities
- Responsible for delivery and management of smaller, less complex, local 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 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 information proactively to stakeholders internally and externally.
- Manage risk and contingencies proactively and lead problem solving and resolution efforts.
- Achieve project quality by identifying quality risks and issues.
- 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.
- 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.
Requirements
- Bachelor's Degree Life sciences
- Minimum 1 year of proven clinical trial management experience.
- At least 3 years of prior work experience as a Clinical Research Associate.
- Therapeutic area knowledge in Oncology.
- Knowledge of job area, 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.
- Fluent language skills in English and good knowledge of Italian at preferably least C1 level.
- Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines and relevant local laws.
- Computer skills including good knowledge of Microsoft Word, Excel and PowerPoint.
- Effective communication, organizational and problem-solving skills.
- Strong leadership competencies and ability to establish and maintain effective working relationship.
- Willingness to work hybrid in Rome with regular visits in the office location (3 times a week).
Benefits
- Flexible work arrangements
- Professional development opportunities
Job title
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Degree requirement
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