Senior Project Manager
hace 3 semanas
As a Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
**What you will be doing**:
- The Study Operations Manager is responsible for study and regional/country level activities from study startup through conduct and study close. The Study Operations Manager will be assigned one or more studies and will be tasked with taking on several responsibilities in support of the larger Study Management deliverables.
- The Study Operations Manager partners with the Global Study Manager, Study Start Up Project Manager, Site Intelligence Lead, Country Trial Manager, Site Excellence Partners, Site Relationship Partners, Site Care Partners, Contracts Lead, Regulatory Affairs, pCRO and others as required to ensure a coordinated approach to study start up, execution and close out.
- The Study Operations Manager has exceptional knowledge in managing and coordinating specific tasks and responsibilities as part of the larger Study Management team
- The Study Operations Manager provides leadership and strategic planning and organization skills to ensure the operational delivery of tasks within one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable
- The Study Operations Manager may be responsible to independently take on the closing out of one or more studies post database lock. Provides back up to or takes on the responsibilities of Global Study Manager as needed.
Regional/Country/Study level implementation of Startup and Site Activation Plans (through SUPM or pCRO if assigned)
- Regional/Country/Study level Recruitment Strategy
- Responsible for development of study level plans
- Communication with internal stakeholders and pCRO as applicable and as listed above to ensure efficient and timely study delivery of the agreed plans
- Responsible for study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
- Responsible for ensuring the follow up and coordination of Regional/site QEs, PDs, data issues, metrics review, site issues/risks, audit responses, etc. The Study Operational Manager will be able to work independently and exercise their own judgement and be a resource for others.
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**You are**:
- Extensive operational clinical trial experience
- 6+ Years of Clinical Trial Management/Clinical Project Management experience
- A scientific or technical degree is preferred along wiextensive knowledge of clinical trial methodology
- Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
**Why ICON?**
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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