Senior Clinical Research Associate, Lisbon

A World's leading Pharmaceutical Services Company is looking for a Senior Clinical Research Associate (SCRA) to join their team in Lisbon.

Responsibilities:

As a Senior CRA you will oversee the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.
Main duties:
* Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
* Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
* Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
* Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
* Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
* May provide assistance to more less experienced clinical staff.

Qualifications/Skills:

* Life Science Degree
* 4 or more years of monitoring experience as in a CRO or pharmaceutical environment
* Preferably with experience in CNS
* Thorough knowledge of ICH Guidelines and GCP.
* Fluent in Portuguese and in English, both written and verbal.
* Well developed communications skills
* Able to work independently.
* Ability to complete tasks in an accurate, timely manner and effectively manage multiple tasks
* Ability to identify and address issues proactively in a timely manner

My client offer career opportunities providing flexibility and growth across the organisation, competitive salary and benefits package, work-life balance initiatives and social events.

If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on.
For a confidential consultation call Esther Manrique on 0044 (0) 207 255 6665 or email your CV to [Email hidden]

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