Clinical Project Manager II
hace 1 mes
We are seeking a highly skilled Clinical Project Manager II to join our team in Barcelona or Madrid. As a key member of our project management team, you will be responsible for overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements.
The ideal candidate will have a strong background in project management, with experience in managing clinical trials and ensuring timely study launch, conduct, and closeout. You will be responsible for leading project teams, ensuring quality, timelines, and budget management, and coordinating activities and deliverables of all study conduct partners.
You will also be accountable for the financial performance of each project and ensure studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements. Additionally, you will be responsible for the quality and completeness of the Trial Master File (TMF) for assigned projects and maintain study information on various databases and systems.
We are looking for a candidate who is passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. We believe that when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Key Responsibilities:
- Manage projects as a project manager overseeing interdisciplinary clinical research studies and ensure compliance with GCP, relevant SOPs, and regulatory requirements.
- Act as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
- Lead project team to ensure quality, timelines, and budget management.
- Accountable for the financial performance of each project.
- Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
- Ensure studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
- Accountable for all project deliverables for each project assigned.
Documentation and Reporting:
- Responsible for quality and completeness of TMF for assigned projects.
- Accountable for maintenance of study information on a variety of databases and systems.
- Responsible for study management components of inspection readiness for all aspects of the study conduct.
- Oversight for development and implementation of project plans.
- Plan, coordinate, and present at internal and external meetings.
- Prepare project management reports for clients and management.
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