Study Data Manager

• Accountability for the quality of CDM deliverables (such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings / Reports / Visualizations) and for the delivery of accurate and reliable clinical study data.

• Liaising directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Central Monitors, Pharmacovigilance, Quality, etc) to coordinate all CDM activities for studies, discussing timelines, and providing CDM updates.

• Defining and implementing data cleaning & validation strategy integrating risk-based approaches.

• Contributing to the protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, and other review activities during the conduct of a study.

• Leading study activities with internal and external (eg, Providers) CDM delivery teams (Database Developers, Data Management Programmers, Central Monitors, etc) and mentoring new Study Data Managers.

• Coordinating all external data activities: specifications, loading and reconciliation, including data collected through Central Labs, eCOA, IRT, connected devices, telemedicine, and mobile healthcare.

Experience : Experience on clinical data management of which 1 years must have been in a project management role.

Soft Skills: Project management skills and experience.
Learn and adapt quickly when facing new problems.
Good interpersonal, communication, and presentation skills.
Technical skills: Experience with CDM and related regulations (incl. ICH E6 and E8).
Risk-based mindset focusing on Quality by Design (QbD) and on what really matters.
Languages: Strong English skills (verbal and written), ability to exchange fluently in a global environment.

Education : bachelors degree or above, preferably in a life science or drug development related field.

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, we'll-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and we'llbeing benefits including high-quality healthcare, prevention and we'llness programs and at least 14 weeks gender-neutral parental leave