Our Senior Site Activation Manager (Sr. SAM) is primarily responsible for the identification and activation of clinical sites and acting as the study functional lead for the Central Site Services team. The Sr. SAM 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.

Position Responsibilities/Accountabilities:

• Maintain and coordinate logistical aspects of assigned clinical trials according to GCP and ICH relevant SOPs. Clinical Trial Responsibilities/Accountabilities:
• Participates in hand over 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.
• Escalate 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.
• 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).
• Assist to coordinate and completes site contract and budget templates development.

• Project Oversight and KPI Responsibilities:
• Track and report on study startup KPIs.
• Collate and communicate study startup site activation performance metrics, issues and lessons learned to appropriate parties.
• Manage, process, and communicate protocol amendment processing status, site performance metrics, issues, and lessons learned to appropriate parties.

• Process Development Responsibilities:
• Identify the need and support development of the CSS specific SOPs.
• Assists with department activities and initiatives, as appropriate (e.g., process improvement, clinical system subject matter expert).

• Fiscal Responsibilities:
• Identify scope of work changes for the SAM role and work with the PM to secure change orders.

• QA and Study Audit Responsibilities:
• Responsible for ensuring that project documentation is complete and audit ready.
• Participate in the audits.
• Address questions in the audit reports.
• Support study audits and respond to audit reports.

Business Development Responsibilities: · Take Part in Bid Defenses and may review RFPs budget as applicable

• Additional for South Korea - based employees:
• Development and review of the Regulatory Core Submission Package.
• Oversee the develop, Prepare, Collect and Review country and site-specific submission documents for MFDS and IRBs · Complete and Perform MFDS portal application
• Prepare and submit SUSARs and safety information to MFDS
• Perform or assist Safety office role in Korea
• Oversee or Review and prepare any RA/IRB queries received within the requested timelines; manage the portal applications.
• Prepare and complete any study regulatory notifications through portal
• Perform or assist any Import License and Export License applications, when required, if applicable for the country per protocol and country requirements.
• Perform or oversee with the country IP drug label review.
• Oversee the completes site contract and budget negotiations.
• Develop Ancillary Budget and Contract templates, when needed (e.g., Laboratory, Pharmacy, Radiology) and perform ancillary contracted negotiations with the external/internal facilities and track the negotiation progress.

Managerial Requirements/Responsibilities: N/A

Position Qualifications/Requirements:

Education: University degree or equivalent education in a related field of study.

Experience: At least four (4) years in pharmaceutical research field (CRO, pharma, site, etc.) and four (4) years of applicable industry experience as part of a Regulatory/site Start-Up team or as part of other equivalent role with regulatory and start-up experience.

Required Certifications: N/A

Required Skills:

• 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 FDA 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.
• Ability to coordinate, oversee, independently evaluate, and lead cross functional teams on the requirements of all aspects of site activation across a study for their country of responsibility, including but not limited to site training, access, IP availability, and other requirements for activation as applicable.
• Proficient with Microsoft Office Suite.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Strong interpersonal skills.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Occasional travel to closest Catalyst or Sponsor office, as needed.