Trial Delivery Specialist – Clinical Trial Coordinator

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Coordinate, manage, and finalize assigned trial activities as per the task matrix.

• Conduct reviews of departmental, internal, country, and investigator files and document the findings.

• Ensure that assigned tasks are completed punctually, within budget, and meet high-quality standards.

• Communicate project risks to project leads and the line manager.

• Maintain documentation specific to the study, including team lists, training trackers, system access management, and project activity plans.

• Keep the electronic Trial Master File (eTMF) current and document review findings.

• Provide system support, including GoBalto and eTMF.

• Assist with risk-based monitoring (RBM) activities.

• Process documents for the client eTMF, conduct eTMF reviews, manage mass mailings and communications, and provide reports to internal team members.

• Schedule and organize client/internal meetings and take meeting minutes.

• Review and track local regulatory documents.

• Transmit documents to the client and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Assist in clarifying and resolving site-documentation findings.

• Maintain vendor trackers.

• Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials, as well as non-clinical study supplies to sites.

• Assist with study-specific translation materials and ensure translation quality control.

• Attend kick-off meetings and take notes when required.

• Serve as a cross-functional liaison and potential study lead.

• Support onboarding as a buddy and train new staff as necessary.

• Contribute to departmental and cross-functional process-improvement initiatives.

⛳️ Requirements

• High/Secondary school diploma or equivalent, along with relevant formal academic/vocational qualifications.

• Bachelor's degree is preferred.

• A minimum of 4 years of prior experience that provides the knowledge, skills, and abilities to perform the role.

• Equivalency through a combination of relevant education, training, and/or related experience may be acceptable.

• Capability to work both in a team setting and independently.

• Strong organizational skills with a keen attention to detail.

• Proven ability to manage multiple tasks efficiently and effectively.

• Ability to analyze project-specific data/systems for accuracy and efficiency.

• Strong customer-centric focus.

• Flexibility and adaptability to reprioritize workload as necessary.

• Knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.

• Excellent English language skills, both written and spoken, with proficiency in local language skills as needed.

• Strong presentation abilities.

• Proficiency in MS Office applications (Word, Excel, and PowerPoint).

• Ability to learn clinical trial database systems.

• Capability to successfully complete the PPD clinical training program.

• Self-motivated with a positive attitude and strong interpersonal skills.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.