Junior Biosample Operations Manager

Descripción del puesto:

Junior Biosample Operations Manager

The Junior Biosample Operations Manager (Junior BOM) plans and coordinates all operational activities for the collection, processing, storage and delivery of biomarker (BM), pharmacogenetic (PGt), immunogenicity (IM) and pharmacokinetic (PK) samples (in following: "biosamples") within Phase I clinical study with dedicated Phase I units (CRO) without involvement of a central lab, while being simultaneously assigned to multiple no CL (central lab) studies.

The Junior Biosample Operations Manager provides sound biosample management expertise to the study management team and is accountable for ensuring that biosamples collected are of optimal analyzable quality and are collected in adherence to the highest standards and informed consent.

The Junior Biosample Operations Manager is responsible for training of the Phase I unit (CRO) on all topics regarding biosampling handling. The Junior Biosample Operations Manager is the primary interface for operational activities between the CRO, the Bayer Study Management and laboratories performing biosample analysis and is the first point of contact for all aspects of biosample handling.

2. Geographical Scope

* Regional

3. Responsibilities of Position

* Plans, organizes, monitors and enforces the collection, processing, storage and logistics of biosamples within a Phase I study at dedicated CROs.

* Accountable for either preparation or initiating of preparation of study related documents (mini biosample management plan, sample handling sheets, etc.) as well as development of shipment schedules, sampling and storage requirements in close collaboration with CRO, Bioanalyst and Assay Technology Expert.

* Support the content of PK, IM, PGt and BM sections of the clinical study protocol, Informed Consent Form and review of biosampling pages in EDC.

* Responsible for handling of samples according to protocol, SOPs, GCP and ICH-guidelines.

* Supports the study team with the submission to IRBs and ECs and responds to IRB/EC requests.

* Responsible for the tracking, monitoring and documentation of biosampling activities.

4. Value Added to the Success of the Company

The position holder adds value by ensuring provision of high quality biosamples from Bayer clinical Phase I trials. The consistently reliable quality of biosamples is a major prerequisite for meaningful subsequent analyses.

Clinical development programs rely on high quality samples for PK, IM, PGt analyses or BM-defined patient selection in the context of Personalized Medicine. Missing biosamples or lack of biosample integrity may critically impair the outcome of clinical trials and acceptance of submission by regulatory authorities and has therefore a high impact.

5. Contribution Context

* Individual Contributor

* Team Member

The position is located within Clinical Development and Operations. Therefore, the most important internal work relationships are with members of the Clinical Teams, especially the Clinical Pharmacokineticist, Bioanalysts, the Biomarker Project Leader, Assay Technology Expert, Clinical Lead, Study Lead Monitors, Study Data Managers and Study Managers.

The most important external work relationships are with CROs selected and contracted for laboratory support, site staff involved in clinical trials (investigators, study nurses), analysis laboratories and Institutional Review Boards or Ethics Committees.

Qualifications and Experience

* Degree in Life Sciences (BSc, MSc).

* A minimum of 2 years' experience in clinical research, with good understanding of clinical development processes (e.g. study management or CRA).

* Detailed knowledge of the ethical, legal and logistic requirements of obtaining and processing human biological samples.

* Proven clinical development experience of working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator site.

* Proven ability to plan, organize and manage multiple projects under pressure.

* Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.

* Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams).

* Effective communication and negotiation skills in English.

Impact

This position ensures consistent quality of biosamples, which is a major prerequisite for meaningful subsequent analysis and thereby has a major influence on the primary outcome of the Phase I studies and subsequent acceptance of the submission package by regulatory authorities.

Application Period:

21/04/2026 - 6/05/2026

Reference Code:

867536

Division:

Pharmaceuticals

Location:

Spain : Cataluña : Barcelona

Functional Area:

Clinical Development & Operations

Position Grade:

VS 1.1

Employment Type:

Regular

Work Time:

Full Time

Contact Us

Address

Telephone

E-Mail

Av. Baix Llobregat, 3, 08970 Sant Joan Despí,
Barcelona, Espanya

+34 93 495 69 99

talentacquisition@bayer.com