50557MKP - Senior Clinical Data Manager (Bayer sl)

This offer is part of the Biomedicine and Health Talent Marketplace organized by Barcelona Activa in collaboration with CATALONIA.HEALTH during the Connection Day. BAYER SL    is looking for the profile Senior Clinical Data Manager

Only people who meet the profile requested by the company will be notified.

The pre-selected people will receive an email from Barcelona Activa with the confirmation of attendance and organizational details.

Once pre-selected, your availability for the Job Marketplace will be requested: Tuesday April 29th, from 15h to 18h, *location to be determined.

FUNCTIONS AND TASKS:

. BAYER visionaries. facilitates a varied and meaningful career in a community of bright and diverse minds to make a real difference.

.decision making in research or development phases, and for the preparation of submission data and required documentation for regulatory authorities andthe greater clinical research community. The
Senior Clinical Data Manager
may assume the business role of a Study Data Manager in one or moreclinical studies. In this capacity, s/he serves as the primary contact for Data Management on the Core Study Team. As an SDM, the
Senior Clinical DataManager
leads the DM team, which is comprised of several extended study team members, to ensure data management deliverables meet, or exceed,corporate and industry quality standards in a timely and cost efficient manner. This includes the co-accountability with the Statistics Lead to create,maintain and manage the Project Plan. The
Senior Clinical Data Manager
may also support research-driven activities, or support the handling of dataprovided by highly specialized functions (e.g., Pharmacokinetic data, Biomarker data) ensuring data management best practices, and the usability of thegenerated data in regulatory processes.
The
Senior Clinical Data Manager
may also assume the role of a Project Data Manager (PDM) or Early Project Data Manager (EPDM). In this role, thePDM/EPDM is a key driver of medical standards implementation and maintenance at the project level
as well as ensuring a consistent standards handlingin the project’s studies
. This critical responsibility is necessary to ensure the project data is aligned with the Clinical Development Plan. The PDM/EPDMensures consistency across studies through close interaction with the Clinical Project Team or Early Clinical Team, mentoring/coaching of SDM(s) andoverseeing the Project Data Management team.
Scope:
Global
Major tasks and responsabilities:
DM Expertise
- Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinicaldevelopment phases. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members,leading or contributing to expert working groups (e.g., QSD initiatives), presenting best practices at internal and external industry meetingsmeetings/congresses, and participating in due diligence assessments.
PDM/EPDM tasks
- Governs use of key data management elements across studies in assigned projects: assumes ownership of development and maintenance of MedicalStandards relevant to the area of responsibility; contributes to the definition of data structure standards; review applied results of the Important MedicalEvent (IME) List and, medical coding conventions.
- Ensures adequate application of Data Management Best Practices across studies within assigned projects: review Study Team documents for projectconsistency; ensure the adequate documentation of all data management activities according to SOPs.
Incorporates and maintains Medical Standards in clinical studies and projects for all elements of the medical standards package.

•  YOUR APPLICATION

  Bayer is committed to treating all applicants fairly and avoiding discrimination. Bayer is the company for you if you are interested

  Type of contract: Permanent

  Number of hours per week: 40h
  Schedule: 9h to 18h. Hibrid
  Gross annual remuneration: within the Offices and Offices Agreement. According to interview