Site Activation Manager
- Expired: over a month ago. Applications are no longer accepted.
Catalyst Clinical Research is a niche provider of clinical research services through two established solutions- Catalyst Flex and Catalyst Oncology. Here at Catalyst Clinical Research we provide support and services exclusively to biotech companies because we know and understand the biotech environment. Our 15+ years of experience allow us to quickly grasp the evolving needs of our clients so we can deliver the solutions essential to meet the evolving needs and unexpected changes inherent in oncology development. When protocols amend or emerging data suggest a breakthrough straight from Phase I to registration, we are ready.
Position Description: As a Site Activation Managers(SAM), you will primarily be responsible for the identification and activation of clinical sites and acting as the functional lead for the Central Site Services team. You will work 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, experienced team in all functional areas.
- Assists with the facilitation of the study development process including start-up, enrollment, and close-out.
- Assists with the management of study budgets, vendors, invoicing, purchase orders, and requisitions.
- Tracks clinical trial progress, identifies operations issues and escalates issues to the attention of the Project Manager.
- Interfaces with Sponsor representatives and internal project team.
- Assists with the development and coordinates the implementation of clinical trial communications (e.g., teleconferences, newsletters) to keep the study team and trial sites informed of trial status and related information.
- Assists with the development of training tools for the study personnel, vendors, and investigator sites.
- Assists with site identification tasks (e.g. CDA negotiation and execution, site survey/questionnaire completion).
- Reviews essential and non-essential documents from sites to ensure all required documents are accurate and complete.
- Compiles project-related activation packages (e.g. IP release, regulatory submission).
- Supports clinical project system set-up, access requests, and maintenance (e.g. eTMF, CTMS).
- Coordinates and partners with Project Manager(s) and Functional Lead(s) to oversee set-up, maintenance, inspection readiness, and archival of Trial Master File.
- Orders, tracks and ships study supplies, tools, and instruments when required by the study plan.
- Develops Investigator Grants.
- Supports the administration of site payments.
- Supports contract and budget negotiations with sites.
- Inputs study timelines and other required fields into clinical trial database, monitors and updates fields as study timelines or other information changes.
- Assists with the development and maintenance of clinical study and project team rosters and email distribution lists.
- Assists with the coordination of trial and project-related meetings.
- Composes and distributes meeting agendas and minutes, as appropriate.
- Manages study team action items.
- Assists with or facilitates the coordination of virtual or live study training meetings.
- Provide other project support to functional teams, 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.
Education: University degree or equivalent education in a related field of study
Experience: At least one year of applicable industry experience
- 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 site contract/budget negotiation
- Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
- 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
- Ability to work well under pressure and drive projects that affect critical timelines
- Ability to multitask and work in a fast-paced dynamic environment required
- Participates in hand over meeting from feasibility team member
- Coordinates site identification tasks; including but not limited to Site Knowledge Survey (SKS) 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
- Completes site contract and budget negotiations
- 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)
- Supports clinical project system set-up, access requests, and maintenance (e.g. eTMF, CTMS) as needed
- Responsible for filing and quality control of Site ID and activation documents during the start up period in the Trial Master File
- Confirms with Project Manager that all study supplies, tools, instruments Orders, tracks and ships study supplies, tools, and instruments when required by the study plan
- Inputs study timelines and other required fields into clinical trial database, 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
- General office working conditions apply. Employee may be office or home based.
- Travel for meetings or training activities may be required
Catalyst Clinical Research, LLC is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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