Site Activation Manager- Spain

• Participates in hand over meeting from feasibility team member.
• Coordinates site identification tasks; including but not limited to Site Feasibility Questionnaires (SFQs).
• Coordinates confidentiality agreement (CDA) negotiation and execution.
• Compiles site set-up process and develops site activation timeline for each site.
• Works with the study team to determine the IP Document Package requirements.
• Completes templated documents with study specific information.
• Develops IP Documents Release Package cover letter and gain approval as required.
• Coordinates and distributes the Essential Document Package (EDP) to the clinical sites.
• Reviews essential and non-essential documents from sites to ensure all required documents are accurate and complete.
• Develop Country/Site submission packages, per country requirements.
• Perform Competent Authority and Ethics submissions per country/site regulatory processes.
• Develop Submission Package to perform supplementary submissions, if applicable per country regulations.
• Coordinates the development of the site contract and budget templates.
• Develop Ancillary Budget and Contract templates, when needed (e.g. Laboratory, Pharmacy, Radiology) and perform facility negotiations and track the progress.
• Completes site contract and budget negotiations.
• Support with Import License and Export License applications, if applicable, per protocol and country requirements.
• Track the progress of site ID, Submissions, and Site Contracts negotiations activities in a Start-Up Reporting tracker/tool
• May support with country label reviews per regulations and country requirements
• Interfaces with Sponsor representatives and internal project team
• Compiles project-related activation packages (e.g. IP release, regulatory submission)
• Responsible for ensuring the filing and quality control of Site ID and activation documents during the startup period in the Trial Master File
• Confirms with Project Manager (or designee) that all study supplies, tools, etc. are available to ship to site in time for Site Initiation Visit (SIV).
• Inputs study timelines and other required fields into the tracking system, monitors and updates fields as study timelines or other information changes.
• Escalate study issues appropriately and in a timely manner.
• Assists with the development and maintenance of clinical study plans.
• Responsible for understanding the CSS budget on each project and the actions required to maintain it.
• Coordinates site ID and activation related meetings including agendas, decision logs and action item tracking.
• Collaborates and supports the project team with amendments to the protocol, ICF, site contract and site budget as needed.
• Assists with department activities and initiatives, as appropriate (e.g., process improvement, clinical system subject matter expert).
• Assists with mentoring or training junior staff.

• Must have demonstrated expertise in relevant clinical and/or business operations activities; including but not limited to site regulatory document collection/review, ICF development/negotiation and/or site contract/budget negotiation.

• Strong ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.

• Strong working knowledge of ICH/GCP guidelines and local country ethics and competent authority regulations (requisite knowledge may be obtained during performance of job duties through appropriate training (both on site and/or e-training programs).

• Exceptional written and verbal communication skills.

• Strong ability to work well under pressure and coordinate multiple tasks that affect critical timelines.

• Strong ability to multitask and work in a fast-paced dynamic environment required.

Catalyst Clinical Research LLC