Manager, Site Management Franchise Lead

hace 3 semanas

Madrid, España Worldwide Clinical Trials A tiempo completo

**Requisition Number**
**6711**

**Employment Type***:
**Regular**

**Who we are**

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

**What Clinical Operations Site Management does at Worldwide**

These roles are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role in every clinical trial. All CROs will promise you growth, opportunity, and maybe even a challenge. But we offer more than that. We offer an uncommon experience - one you can’t get anywhere else, with a team unlike anyone else.

**What you will do**
- Provide therapeutic and operational expertise throughout the program/project delivery lifecycle
- Ensure that projects within the Franchise are properly resourced
- Responsible for collaborating with Therapeutic team to provide effective delivery strategies and solutions for Franchise projects and programs
- Act as main contact person for the Project management Franchise Lead
- Present at Proposal Defense/client meetings as needed to support new or ongoing business
- Ensure CRAs are trained on project specifics
- Ensure LCRAs are trained to support the clinical scope of work (which includes SOP review, QI/CAPA understanding, Clinical Monitoring Plan)
- Coordinate and collaborate, with WCT Global Quality Assurance, to provide training opportunities identified in CAPA information
- Manage the quality of assigned staff's clinical work
- Coordinate efforts between the Project Management, Site Management, and Study Start Up
- Establishing regular communication to include quality metric (SVR compliance, SDV metrics, on site metric discussion, etc.) and overall “health” of the projects (data query status, managing to the SOW, resource status)
- Conduct appraisal performance review for direct reports

**What you will bring to the role**
- Broad protocol knowledge; therapeutic knowledge desired
- Comprehensive global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle and operational clinical trial delivery
- Innovative and strategic thinker
- Superior oral and written communication skills
- Strong planning and organizational skills
- Experienced problem solving/decision making skills
- Good attention to detail
- Understanding of clinical research principles and process, data collection and editing skills.
- Ability to navigate in EDC software (InForm, Medidata, etc.)
- Strong knowledge of FDA regulations, ICH Guidelines and HIPAA

**Your background**
- 4-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and 8 years clinical research experience as a clinical research associate OR
- Equivalent education/training and 10 years clinical research experience as a clinical research associate
- At least 2 years of management experience
- Travel required
- Passport required

**Why Worldwide**

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

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