Marta Caballero Email & Phone Number

Seville, Spain

• Assisting in overall Project Delivery through coordination of efforts assigned to entire project team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety). Facilitates overall study team.
• Collecting information as it pertains to functional department deliverables and milestones through clear communication with the functional leads and use of various study databases. Assists in the identification of.
• Ensuring project delivery is within all contracted timelines.
• Adhering to project budget and scope of work in order to realize project profitability.
• Ensuring assigned projects are audit ready; i.e., project tasks are completed in accordance with project plans and SOPs and are filed to TMF, as appropriate.
• Initiating team communications and documentation internally and externally. May be identified as the backup in the absence of a Project Manager to address internal team member issues and to be the main point of contact.

Seville, Spain

• Support in the preparation and maintenance of project and study-related documents, study plans, instruction manuals.
• Keeping track of study progress, readiness (approved/agreed/available) of relevant study documentation, patient recruitment etc. by preparing and maintaining appropriate trackers.
• Preparation for and coordination of all procedures related to the collection, handling and shipment of starting material and final product (active or placebo) in clinical trials. Responsibilities include, but are not.
• Function as contact person for specific clinical trial vendors to manage related activities, such as translations of documents, courier activities, management of ID-Net users.
• Managing supply of clinical material to clinical sites.
• Responsible for GCP-compliant filing of study related documentation for clinical studies, by liaising with the responsible CRO and by reviewing completeness and correctness of Trial Master Files/Investigator Site Files.

Madrid Area, Spain

Providing support to Project Leader and Functional Leads:. Set up and maintenance of study internal systems, tools and processes: eTMF, Project Management Plan, study status reports, SOP lists.. Set up and maintenance of CTMS and Project Schedule.. Arrange project related training for team members under the direction of Functional Leaders, maintain project.

Madrid Area, Spain

Providing support to Clinical Team Manager and Project Manager:. Set up and maintenance of team lists, site staff lists and vacation lists, keeping team training records and materials. Tracking project handovers between study team members.. Conference calls set up and minutes preparation, assisting in the organization of investigator/team meetings.. Set up.