International position|Barcelona based

Multinational Biotech Company

To support the Clinical Development Physicians in the execution and delivery ofall medical monitoring activities of a clinical trial and in the provision of medical oversight for clinical trials.

Coordination of safety and medical monitoring related documents and processes (e.g. Trial Oversight Committee [TOC] charter and TOC meeting/committee process, Adjudication Committee [AC] charter and AC meeting/committee process, Medical Monitoring Plan and associated documents/trackers, Data and Safety Monitoring Board [DSMB] charter and DSMB meeting/committee process, etc).

To monitor the pharmacovigilance (PV) requirements and activities of a clinical trial in close collaboration with the Physicians.

Review and input into PV related documents (e.g. Safety Management Plan [SMP], Development Safety Update Report [DSUR], Risk Management Plan [RMP], etc.).

Act as a liaison between Clinical team and PV team on processing and tracking of safety events, Serious Adverse Events reports, narratives, etc., during conduct of clinical trials.

Act as a liaison between Clinical team and PV team on completion and review of PV specific regulatory documents during conduct of clinical trials.

To support the clinical study team in the set-up, execution and delivery of qualitatively robust clinical trials.

Active involvement (contribution, preparation, participation) in trial related meetings where PV/Medical Monitors input is required regarding subject safety and/or product related safety events, e.g. Blinded Data Review Meeting,

Investigator meetings, Kick-Off Meetings, Bid Defence Meetings, etc.

Close cooperation with other key stakeholders (Clinical Science Team,Clinical Development Team, Clinical Operations, PV, Quality Assurance Team, Regulatory Team, etc.) and external parties (e.g. Contract Research Organisations [CROs], vendors, Key Opinion Leaders [KOLs], etc.) to support clinical trials as required.

Input to and review of trial specific documents/tools from safety and medical perspective, e.g., Protocol, electronic Case Report Form (eCRF), IB, study specific plans, Clinical Study Report (CSR), etc.

Involvement in the defining clinically relevant methodologies e.g. nasal provocation test (NPT), anaphylaxis procedures, etc.

Contribution to writing, review, development and introduction of Standard operating procedures (SOPs).

Maintains current awareness of applicable regulatory guidelines (including their interpretation) for clinical research with special focus on safety related guidelines.

Demonstrates and promotes the company values & vision.

Carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and others.

Comply with all GSK regulations applicable to the Freeman Building (if applicable).

Control and maintain your personal training folder.

Comply with all Company policies and procedures.

Carry out any other reasonable request as directed by your Manager.

Follow a code of conduct conducive to a professional environment.

Exhibit professional behaviours at all times whilst on site or on company business.

Partake in the Performance Management system process as directed by management.

Engender a positive Can Do approach within the team and cross-functionally to drive forward agreed initiatives, meet business needs and seek a consistent approach across areas.

Flexibility

Excellent opportunity for professional development

Social benefits