Clinical Trial Associate (M/F)

工作内容

Celyad Oncology is looking for a Clinical Trial Associate. The successful candidate will be based in Belgium and will report into the Head of Clinical Operations.

Role & Responsibilities :

Job purpose is to support all activities related to the clinical studies from protocol summary, study site selection and regulatory activation process to Clinical Study Report:

• Establish and maintain key clinical operations databases (enrolment, KPIs, material shipments, site contacts, essential documents, etc.);
• Setup and maintenance of Trial Master Files and Investigator Office files;
• Manage documentation of clinical studies in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs);
• Support organization of Clinical meetings (internal meetings, CRA meetings, investigator meetings, etc.) incl. agenda, minutes and logistics;
• Act as central contact for the clinical operations team for department communication, correspondence, and associated documentation;
• Actively support the CTM and team to :

Perform study sites activation;

Establish & maintain excellent relationship with study sites;

Ensure study process improvements implementation (i.e. input in SOPs/WI).

• Prepare all external & internal documentation for assigned trials (as per study protocol, SOP’s, and GCP requirements).

Qualifications & Experience :

• Bachelor or Master’s degree in a (para-) medical or scientific field;
• 3+ years, at least, of experience in a similar role;
• At least two years of working experience within biotech industry or hospital, highly desired;
• GCP training and certification are mandatory.

Skills & Competencies :

• Creative and finding ways to get the job done;
• Thriving in challenging environments and finds ways to remove obstacles;
• Flexible mindset capable to manage change and deal with ambiguity;
• Proven ability to navigate complex projects;
• Autonomous, pro-active, flexible and assertive personality. Driven to achieving highest results;
• Efficient in planning and executing work: ability to multi-task yet prioritize activities at once;
• Team player, able to navigate into matrix organization in multi-cultural environment;
• Very strong attention to details;
• Ability to organize and classify complex technical documentation;
• Excellent communicator able to structure information and share it within the team and across departments;
• Hands-on attitude;
• Proficient with Microsoft office suite;
• Fluent in English and French or Dutch knowledge (oral and written), additional languages are an asset.

For more information about this position or about the Company, please contact us by email at job@celyad.com