Clinical Study Excellence Scientist

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Clinical Study Excellence Scientist**

**Purpose**:
The Clinical Study Excellence Scientist (CSES) is the point of contact and responsibility for all aspects of a trial within the study team, with the aim of ensuring the safety of study participants, the quality of data and the success of the development project. As a member of the Global Clinical Sub-Team (GCT), the CSES will support the GCT with expert knowledge and insight into the study.

**Scope**:Global

**Main responsibilities**:

- Primary contact person during the study for protocol and safety questions for one or more trials (for which he / she has as an in-depth understanding of protocols and protocol requirements)
- Responsible for designing the medical review strategy and developing the Medical Review Plan
- Contribute to the content of sections of clinical study protocol and other study-related documents/publications that require scientific input, in collaboration with the GCL and other relevant functions (including but not limited to ICF, eCRF, CSR, Narratives, IB, DSUR).
- Provides input into eCRF development and participates in eCRF user acceptance testing (UAT) and final approval of the eCRF.
- Understands the asset’s biological mechanism, clinical strategy, safety profile, scientific interpretation of disease, and target-based literature.
- Provides medical input at SIV and Investigator Meetings and in collaboration with the GCL may present the medical background, rationale for the trial and relevant sections of the protocol.
- Supports the Clinical Lead for the presentation of clinical/safety data to DMC, SCs, internal governance committees and external consultants.
- Trains or contributes to the training of study team, CRAs/CLMs, site staff and CRO staff (if applicable) on medical aspects of the study, indication, and compound.
- Queries identifiable safety-related medical discrepancies or requests for clarification in the appropriate EDC and related systems.
- Coordinates with Clinical Lead to provide consistent replies to health authorities, including local Ethics committees (ECs)
- Reviews incoming medical data, on both accumulative and individual basis.
- Develops a safety aggregated report periodically for cross
- functional review with specific attention to Adverse Events [Treatment
- Emergent Adverse Events (TEAE), Related TEAE)], Treatment-Emergent Serious Adverse Events (TESAE), Adverse Events of Special Interest (AESI), worst Post-Baseline Laboratory Shift Tables, Study Status, Summary Table, AE Summary, SAE Summary
- Supports medical protocol deviations cross-functional review, as appropriate.
- Contributes to the conduct of study feasibility assessments. Collaborates effectively with study team on study deliverables, as appropriate.
- Contributes to the selection of vendors for the outsourcing of clinical trial services.
- Supports the coding of reported terms for medical history, concomitant medications, and adverse events.

Trains or contributes to the training of study team, CRAs/CLMs, site staff and CRO staff (if applicable) on the study, indication, and compound

**Value added**:The CSES ensures the safety of study participants, the quality of data and an optimal development of the Investigational Medicinal Product.

**Working relations**:

- Core Study Team
- Global Clinical Lead / Clinical Development Lead/ Early Clinical Lead
- Global Safety Lead
- Data Monitoring Committee / Steering Committee/ Adjudication Committee/ External Experts
- Country Lead Monitor / Clinical Research Associate

**Qualifactions**:

- MD, DO, PhD, PharmD, RN with 3-5 years of clinical trial scientist experience (or equivalent).
- Fluent in English, both written and spoken.
- Collaborative and team-oriented worker.
- Sensitive to diverse global cultures.
- Strong communicator for both scientific discussions and study center training.

**YOUR APPLICATION**

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

**Location**:
Spain : Cataluña : Barcelona

**Division**:
Pharmaceuticals

**Reference Code**:
847564