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, train new staff and support process-improvement initiatives. The schedule is standard, Monday to Friday, in an office setting.

Key responsibilities

• Coordinate, oversee and complete assigned trial activities according to the task matrix, and perform department, internal, country and investigator file reviews.
• Ensure tasks are done on time, within budget and to a high quality standard, and communicate risks to project leads and managers.
• Maintain study documentation and support systems such as GoBalto and eTMF, including study team lists, training tracking, system access management and activity plans.
• Support RBM activities and perform administrative tasks such as document processing, mass mailings, meeting scheduling and minutes, and review of local regulatory documents.
• Analyze and reconcile study metrics, assist with site documentation clarifications, maintain vendor trackers, and help compile Investigator Site Files and pharmacy binder materials.
• Assist with translation materials and QC, and may attend kick-off meetings and take notes.

Required profile

• High or secondary school diploma or equivalent, with a Bachelor's degree preferred.
• Previous experience comparable to at least 4 years; equivalency through education, training and experience may be accepted.
• Good English and grammar, with proficient local language skills as needed.
• Ability to complete the PPD clinical training program.

Required skills

• Proficiency in MS Office (Word, Excel, PowerPoint).
• Ability to learn and master clinical trial database systems.
• Knowledge of country regulations, ICH GCP and client SOPs and WPDs.
• Strong organizational skills, attention to detail and data analysis skills.