As a Site Activation Manager I (SAM I) you are primarily responsible for the identification and activation of clinical sites and acting as the study functional lead for the Central Site Services team. The SAM I works directly with the Project Manager, Clients, Vendors, and other internal functional teams to ensure quality deliverables on-time and on-budget. Our mission is for our Catalyst staff to operate seamlessly with our customer teams using the Catalyst site centric model to enhance employee satisfaction while giving the sites and customers the reassurance that they have a strong and experienced team. SAM I is a junior role and requires close supervision from a Senior SAM role as a mentor and/or management oversight.
Position Responsibilities:
Clinical Trial Responsibilities and Accountabilities:
- Participates in handover meeting from feasibility team member.
- Coordinates site identification tasks; including but not limited to Site Feasibility Questionnaires (SFQs).
- development/distribution/collection/analysis, and confidentiality agreement (CDA) negotiation and execution.
- Compiles site process and timeline information.
- Develops site activation timeline.
- Works with the study team to determine the Essential Document Package (EDP) requirements.
- Completes templated documents with study specific information.
- Develops EDP cover letter and gain approval as required.
- Coordinates and distributes the EDP to the clinical sites.
- Reviews essential and non-essential documents from sites to ensure all required documents are accurate and complete.
- Manages Central IRB vendor.
- Coordinates the development of the site contract and budget templates.
- Tracks site identification and activation progress, identifies operations issues and escalates issues to the attention of the Project Manager.
- Interfaces with Sponsor representatives and internal project team.
- Compiles project-related activation packages (e.g., IP release, regulatory submission).
- Responsible for 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.
- Escalates study issues appropriately and in a timely manner.
- Develops and maintains the site start up plan.
- Assists with the development and maintenance of clinical study plans.
- 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.
Project Oversight and KPI Responsibilities:
- Tracks and reports on study startup KPIs.
- Collates and communicates study startup site activation performance metrics, issues, and lessons learned to appropriate parties.
Process Development Responsibilities:
- Contributes to SOP and JA updates and development.
QA and Study Audit Responsibilities:
- Responsible for ensuring that project documentation is complete and audit ready.
- Participates in the audits.
- Addresses questions in the audit reports.
- Supports study audits and responds to audit reports.
Position Qualifications:
Education: University degree or equivalent education in a related field of study.
Experience: At least two years in pharmaceutical research field (CRO, pharma, site, etc.) and 2 years of applicable industry or experience as part of a site start up team.
Required Skills:
- Working knowledge of ICH/GCP guidelines and FDA, UK and/or European regulations as applicable (requisite knowledge may be obtained during performance of job duties through appropriate training (both on site and/or e-training programs).
- Ability to work well under pressure and coordinate multiple tasks that affect critical timelines.
- Ability to multitask and work in a fast-paced dynamic environment required.
- Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.
- Must have demonstrated expertise in relevant clinical and/or business operations activities; including but not limited to site regulatory document collection.
- Ability to coordinate and oversee all aspects of site activation for site workload, including but not limited to site training, access, IP availability, and other requirements for activation as applicable.
- Ability to deal effectively with a diversity of individuals at all organizational levels.
- Exceptional written and verbal communication skills.
- Ability to read, write and speak fluent English.
- Excellent Client facing presentations skills.
- Good working knowledge of a range of computer applications.
- Proficient in Microsoft office (Word, Excel, PowerPoint).
- Occasional travel to closest Catalyst or Sponsor office, as needed.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.
Application