Clinical Specialist

EPM Scientific; Egham; On-site; GBP 35,000 - 50,000; Full time

Job summary

A global leading Biotech company is seeking a Clinical Specialist / Junior Clinical Research Associate in Egham, UK. The role involves conducting site evaluations and managing operations for the SCENESSE® distribution, ensuring compliance with ICH-GCP guidelines. Responsibilities include monitoring data collection, maintaining communications with clinical sites, and preparing submissions for regulatory authorities. We are looking for a detail-oriented individual ready to make a significant impact in the biotech field.

Qualifications

• Experience with ICH-GCP guidelines.
• Ability to maintain communication with clinical sites.
• Skills in document collection and submission.

Responsibilities

• Conduct site evaluation and setup for SCENESSE® commercial distribution.
• Maintain communication with sites involved in clinical distribution.
• Monitor data collection and safety reporting at study sites.
• Manage site operations including supply management.
• Prepare and submit documentation to regulatory authorities.

Skills

Site evaluation

Clinical project management

Data monitoring

Communication

Job description

Job Description

Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process?

Our Client, a global leading Biotech company is looking for a Clinical Specialist / Junior Clinical Research Associate.

Tasks

• Conduct site evaluation and setup for SCENESSE® commercial distribution, including dosing training in collaboration with the Clinical Project Manager or designee
• Maintain communication with sites involved in SCENESSE® commercial distribution and potential clinical trial sites
• Collect essential documents in compliance with ICH-GCP E6 (R2) and applicable regulations
• Monitor data collection and pharmacovigilance / safety reporting at post-authorisation study sites
• Manage site setup, initiation, monitoring, and close-out for clinical and post-authorisation studies as needed
• Oversee site operations including supply management and payment processes
• Track study and clinical trial status and provide progress updates to the team
• Prepare and submit documentation to EC / IRB and regulatory authorities
• Participate in investigator meetings, and relevant conferences
• Contribute to newsletters and other communications as directed by the Clinical Project Manager or designee
• Assist with audits as required

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