Project Manager Ii

hace 4 días


Madrid, España Premier Research A tiempo completo

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional **Project Manager **to bring your passion to our **Dermatology** team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

The **Project Manager II** (PM II) leads, plans, organizes and oversees all activities related to the execution of clinical trials that are moderate to large in size and complexity and take place within multiple regions.

The **Senior Project Manager (SPM)** leads, plans, organizes and oversees all activities related to the execution of complex and/or international clinical trials and/or programs.

Both roles provide customer-focused leadership from inception to execution through completion to achieve on-time, on-budget project results with high quality.

As both a PM II and SPM you'll be accountable for:

- Ensuring successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
- Ensuring adherence to project budget and scope of work to realize project profitability
- Ensuring all project tasks are completed in accordance with project plans and in compliance with standard Premier Research processes, policies and procedures
- Ensuring effective communication is maintained and project status reports and monthly progress reports are provided both internally and externally
- Ensuring compliance for project-related training
- Ensuring adequate resourcing is available to meet project deliverables and milestones

As a PM II you will need this background to be considered:

- Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
- 6 years relevant experience, preferably in a pharmaceutical company/medical device company/CRO including 2 years of clinical project management or clinical management experience
- 3 years of experience in managing progressively large and complex scientific research projects, at least half of which has been in a matrix environment
- Served as a Project Manager for one or more small/non-complex projects
- Strong budget/finance experience on a project level

As a SPM you will need this background to be considered:

- Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
- Minimum 8 years relevant experience, preferably in a pharmaceutical company/medical device company/CRO, at least half of which has been in a matrix environment
- 5 years of experience serving as a Project Manager for complex and/or international clinical trials and/or programs
- Budget/finance/costing experience on a project level
- Experience in coaching/mentoring other PMs
- Experience managing a study from start to completion, managing multiple phases, and managing the full life-cycle
- Global experience preferred
**You’ll need strong demonstrated knowledge of**:

- Therapeutic and protocol disciplines in dermatology
- ICH/GCP regulations
- FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
- Project Management principles
- The clinical development process
- Full-service functional areas
- Web-based communication tools for conferences.
**You also must be**:

- Available to travel
- Fluent in English, with strong oral and written communication skills
- Able to lead and motivate team members
- A highly confident and effective presenter
- Skilled at multitasking, meeting deadlines, and working effectively in a fast-paced environment with competing priorities
- Skilled at handling problems decisively and objectively
- A self starter

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