Manager (m/f/x) Data Management

Stellenbeschreibung:

Passion for Innovation. Compassion for Patients.

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.

Our European headquarters are in Munich, Germany.

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. The role partners with internal and external stakeholders to optimize data management technology, processes, and standards.

Roles and Responsibilities

Establish data management strategy at project/study level and proactively identify and manage risks for a smaller number of projects/studies.
Plan and direct data management activities for assigned projects/studies through outsourcing (study startup, conduct, closeout, reporting).
Provide oversight for data management CRO and third‑party vendors to ensure compliance with GCP, regulatory guidelines, and company SOPs.
Ensure data management deliverables meet or exceed expectations regarding quality, time, and cost and that documentation is filed/archived according to applicable requirements.
Review and approve clinical study related documents (protocols, data management plan, reports) and lead data review process to ensure data quality.
Participate in audits and inspections.
Provide comprehensive data management expertise to optimize study‑specific clinical trial processes and participate in continuous improvement initiatives.

Personal Skills and Professional Experience

Master’s degree in life sciences or related field.
At least 5 years of professional experience in data management within a medical device or pharmaceutical/biotechnology company or similar environment (e.g., CRO).
Excellent communication, collaboration and project planning skills.
Fluent business English (oral and written).
Proven track record of collaboration with CROs and experience leading projects or initiatives.