Head of Data Management

We are a private, newly created, and non-profit Foundation, linked to the Hospital Clinic de Barcelona, whose mission is to strengthen public health and improve the quality of life of citizens. To respond to our founding goals, we have an academic CRO for conducting clinical studies, initiated by the pharmaceutical and health technologies industry or by researchers, both in the field of medicines and medical devices, offering a comprehensive portfolio of services to meet the needs of our customers. We are looking for a talented and motivated Head of Data Management.

The Head of DM is the responsible for managing the strategy and its implementation, the resources within the DM department for the proper design, validation, implementation, maintenance, and close-out of electronic Case Report Forms (eCRFs), to fulfill clinical study protocol and regulatory requirements. He/she ensures the adequate plan and implementation of the relevant risk-based DM activities.

Main Responsibilities

• Providing internal leadership across the DM activities managed by BCCC

• Providing status update of the activities developed in each clinical study to CPMs and others, including the Direction of BCCC.

• Providing consultancy (from DM perspective), when required by the CPM, the OD and/or the Sponsor, about specific matters related to the clinical study protocol design.

• Ensuring the design of the eCRF, in accordance with the study requirements.

• Evaluating the resources required from DM department for each clinical study (staff involved, responsibilities delegation, applicable timelines, and schedule of internal reporting) as based on the needs and requirements of that clinical study.

• Coordinating, and defining (with the applicable support of the DM Supervisor), the Validation Plan (VP) and the User Acceptance Testing (UAT) strategy of every eCRF version designed for each study.

• Collaborate with QA Department, when required and as applicable, in the development of any process coordinated by QA staf

Experiences and qualifications required

• At least 3 years working as Data Manager (or equivalent) within the Pharmaceutical Industry (CRO, Sponsor), including responsibilities related to the maintenance and administration of clinical database applications during the studies conduction

• At least 2 years working as Head of DM (or equivalent) within the Pharmaceutical Industry (CRO, Sponsor), including responsibilities for area management, and further ones related to the risk evaluation, and the eCRFs design and full validation

Bachelor's degree in Life or Applied Sciences, or equivalent (Medicine, Biology, Biochemistry, Pharmacy, Chemistry, etc)

• Postgraduate studies (Master or advanced course) in Bioinformatics, Data Science or similar

• Postgraduate studies (Master or advanced course) in Clinical Trials Research or similar

• Desirable PhD Degree in any of the previous disciplines

• Demonstrable knowledge of statistical tools, especially R-project

• Demonstrable knowledge of programming, specially Javascript; and of server languages (PHP or similar)

• At least advanced English level

• Desirable at least an advanced Spanish or Catalan level

• Used to work or at least familiar with cloud-based IT platforms and tools

• Good communication and reporting

Working conditions

Full time position

Offices located in the center of Barcelona

Working remotely is an option

Competitive Salary

Starting date of the contract: July 2025