- Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies
- Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).
- Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
- Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.
- Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports).
- Leads and drives the data review process in collaboration with the study team to ensure data quality
- Participates in audits and inspections.
- Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.
- May participate in process improvement initiatives.
- Master degree in in life sciences or related field
- At least 5 years of professional experience in data management and/or related work experience in a medical device or pharmaceutical/biotechnology company, or similar environment (e.g. CRO).
- Strong expertise in data management
- Excellent communication, collaboration and project planning skills
- Fluent business English (oral and written)
- Proven track record regarding collaboration with CROs
- Experience in leading initiatives as well as projects
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Manager Data Management - All, España - Daiichi Sankyo Europe
Descripción
Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, 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 strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our Daiichi Sankyo European Headquarters, we are looking for a:
Manager Data Management (m/f/x)
The position:
The position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards. This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third party vendors. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas.
Roles and responsibilities:
Leadership, Direction, and Strategy:
Project Management:
Functional Expertise:
Operational Efficiency / Continuous Improvement:
Personal skills and professional experience:
Why work with us?
Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
