Senior / Site Activation Specialist

vor 1 Monat

Berlin, Deutschland Worldwide Clinical Trials Vollzeit

**Requisition Number**
**6468**

**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 2,500 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 Site Activation does at Worldwide Clinical Trials**

Site Activation is the perfect place to develop and further your career. We emphasize the development of project management and strategic planning skills that will advance you through the opportunities within Site Activation or serve as an excellent pathway to advancement in Project Management or other Clinical Operations groups.

**What you will do**
- Track study-specific site regulatory documents by site and/or country and follows up with sites or internal team members as needed
- Support the adaptation of country/site-specific informed consent forms
- Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
- Interface with relevant functional leads to ensure appropriate prioritization of essential document collection and review to facilitate synchronized start-up
- Collect, receive, and perform first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines and relevant study-specific plans. Implement corrective action as needed, prior to essential document review sign-off and follow up on Non-Hold items post sign off (where applicable)
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate
- Support Site Identification activities including the collection of Confidential Disclosure Agreements and the collection and analysis of Site Identification Questionnaires

**What you will bring to the role**
- Strong written and verbal communication skills to clearly and concisely present information
- Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality
- Strong understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel

**Your background**
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum one year of experience in clinical research, preferably in site activation or regulatory-related function
- Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
- Fluent in German and English language.

**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.

LI-MP1 #LI-Remote

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