Site Activation Manager
Site Activation Manager
Posted on :
16-02-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
16-02-2025
Job Description
Job Title: Site Activation Manager
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Entry level
Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology a fullservice oncology CRO and multitherapeutic global functional and CRO services through Catalyst Flex. The company's customercentric flexible service model innovative technology expert team members and global presence advance clinical studies. Visit CatalystCR.com.
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 ontime and onbudget. 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:
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
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 ontime and onbudget. 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 nonessential 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 projectrelated 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.
- Tracks and reports on study startup KPIs.
- Collates and communicates study startup site activation performance metrics issues and lessons learned to appropriate parties.
- Contributes to SOP and JA updates and development.
- 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.
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 etraining programs).
- Ability to work well under pressure and coordinate multiple tasks that affect critical timelines.
- Ability to multitask and work in a fastpaced 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 computer 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.
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Employment Type
Full Time
Key Skills
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