• Provides support to Clinical Data Management (CDM) project teams by performing various administrative activities • Runs test data for user acceptance testing during startup • Generates user acceptance testing data files post testing • Prepares study-specific metrics reports • Cleans patient tracker • Performs file reviews of the eTMF • Requests access to the electronic data capture (EDC) environment • Creates and maintains study information for CDM teams • Assists with validation of a client's coding dictionary subscriptions • Conducts quality control review of documents • Generates training completion reports • Files final versions of CDM documents

• Guide a team of Project Managers and support staff while serving as a strategic partner to pharmaceutical and biotech clients in their clinical trials journey. • Deliver excellence in project execution, client satisfaction, and team development as you oversee complex global clinical supply chain operations. • Support our mission of enabling customers to make the world healthier, cleaner, and safer by ensuring patients receive appropriate therapies when needed. • Establish and maintain strategic relationships with key stakeholders, coordinate cross-functional collaboration, and implement continuous process improvements. • Oversee portfolio management, resource allocation, and financial performance while supporting team members and cultivating a culture of excellence. • Apply your expertise in clinical trial operations and GMP environment to deliver outstanding service and maintain the highest quality standards.

• Draft, review, negotiate and finalize agreements with study sites • Ensure compliance to established negotiation parameters • Identify and assess legal, financial and operational risks • Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual activities

• Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation • You’ll have the opportunity to provide administrative and technical support to the Project Team. • Coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. • Act as a buddy during the onboarding phase and provide training to new staff as needed. • Support departmental and cross-functional initiatives for process improvements and enhancements. • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. • Ensures allocated tasks are performed on time, within budget and to a high quality standard. • Proactively communicates any risks to project leads and line manager as appropriate. • Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. • Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system. • Provides system support (i.e. GoBalto & eTMF). • Supports RBM activities. • Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. • Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes. • Reviews and tracks local regulatory documents. • Transmits documents to client and centralized IRB/IEC. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • Maintains vendor trackers. Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. • Assists with study-specific translation materials and translation QC upon request. • May attend Kick off meeting and take notes when required.