Regional Site Engagement Manager (RSEM) (m/f/x)

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Date: 31-Jul-2022

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position

 

Regional Site Engagement Manager (RSEM) (m/f/x)
-limited until January 2024-

 

Roles and responsibilities: 

  • Serve as the Daiichi-Sankyo (DS) point of contact across multiple studies at key sites ensuring coordination of activities across multiple DS functions 
  • Coordinate with the Operations Managers, Study Team Leader, Global Clinical Leads (GCL) and the Medical Science Liaisons (MSL) in developing both regional and site-specific engagement strategies
  • Develop a portfolio understanding of site capabilities, clinical trial conduct infrastructure and identify site contacts for Daiichi-Sankyo
  • Support identification of key sites of focus to strengthen site relationships, enhance clinical trial conduct and develop a site-specific integrated plan which will include but not limited to site communication plan and rules of engagement
  • Ensure alignment with CROs on roles and responsibilities in support of site activities 
  • At key sites, assist the study team in the selection, onboarding and establishing timelines for study start-up activities
  • Work with the study team to include the Study Team Leader, Operational Managers, Clinical Development team (GCL, PS, CS) and the Medical Science Liaisons (MSL) to engage directly with site to maintain relationships throughout the course of the trial and develop future opportunities
  • Identify, evaluate and recommend potential investigators/sites on an on-going basis within assigned region for future clinical trial opportunities
  • Initiate, develop and grow professional and collaborative relationships with Principal Investigators, all study personnel and necessary institution stakeholders
  • On an as-needed basis, evaluate output from Trial Feasibility & Site Identification and provide feedback or due diligence on an identified site/center
  • Intensive travelling in EU and to US is required

 

Personal skills and professional experience:

  • Bachelor’s /Master´s Degree in a Life Sciences field and a minimum of 7 of years’ experience
  • 3-5 years of advanced site monitoring/management in support of complex, oncology clinical trials across the development spectrum (Phases 1-3)
  • Knowledge of ICH/GCP and regulatory guidelines/directives
  • Understanding of industry trends (Risk Based Monitoring, Central Monitoring, etc.)
  • Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision-making skills
  • Ability to work independently as well as collaboratively in a global, cross-functional environment
  • Strong written and verbal communication skills in English and German language
  • Demonstrate advanced knowledge of design and phases of clinical studies on a global scale
  • Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint

 

 

What we offer


Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.