Senior Clinical Trial Coordinator

About the role

The company has supported the top 50 pharmaceutical companies and more than 750 biotechs across 2,700 clinical trials in over 100 countries. As a Senior Clinical Trial Coordinator, you provide administrative and technical support to the Project Team, coordinating and facilitating project activities and possibly serving as a study lead and cross-functional liaison. You also act as a buddy during onboarding and train new staff, and support process-improvement initiatives.

Key responsibilities

• Coordinate, oversee and complete assigned trial activities according to the task matrix, ensuring tasks are done on time, within budget and to a high quality standard.
• Review department, internal, country and investigator files, document findings and keep the eTMF up to date.
• Support study documentation, system access management, project training tracking and activity plans, and provide system support (GoBalto and eTMF).
• Perform administrative tasks such as processing documents for clients, mass mailings, preparing meeting minutes and reviewing local regulatory documents.
• Analyze and reconcile study metrics, track vendors, and help compile and distribute Investigator Site File and pharmacy binder materials to sites.
• Assist with translation materials and QC, and may attend kick-off meetings and take notes.

Required profile

• High or secondary school diploma or equivalent; bachelor's degree preferred.
• Previous experience comparable to at least 4 years, or an equivalent combination of education, training and experience.
• Knowledge of country regulations, ICH GCP and client SOPs and WPDs.
• Excellent English and grammar, with proficient local language skills as needed.

Required skills

• Proficiency in MS Office (Word, Excel, PowerPoint).
• Ability to learn and master clinical trial database systems.
• Ability to complete the PPD clinical training program.
• Strong organization, attention to detail, data analysis and customer focus.