With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.
In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.
Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.
We are seeking highly qualified candidates to fill the position of:
Senior Manager Regional Site Engagement Management (RSEM) (m/f/x) Spain
* Serve as the Daiichi-Sankyo (DS) point of contact across multiple studies at key sites ensuring coordination of activities across multiple DS functions.
* In this role you will take over the RSEM responsibilities for Spain and probably 1-2 other European countries.
* Coordinate with the Clinical Operations teams, Clinical Development teams 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 Global Study Teams to include key stakeholder from Clinical Operations, Clinical Development, Clinical Science and Medical Science Liaison (MSL) to engage directly with study sites 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 within Spain, Europe and occasionally to the US may be required.
* Bachelor's Degree in a Life Sciences field.
* 3-5 years of advanced site monitoring and/or study management in support and oversight of complex, oncology clinical trials across the development spectrum (Phases 1-3).
* Knowledge of ICH/GCP and regulatory guidelines/directives, specific knowledge of regulations in Spain required.
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, full professional proficiency in Spanish
* 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.
* Residency in Spain.
* Excellent Benefits
* Work-Life Benefits
* Growth and Development
* Health and Wellbeing Support
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