ResearchEd

Senior Site Activation Manager

ResearchEd

full-time

Posted on:

Location Type: Hybrid

Location: South Korea

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Is primarily responsible for the identification and activation of clinical sites and acting as the study functional lead for the Central Site Services team.
  • Works directly with the Project Manager, Clients, Vendors, and other internal functional teams to ensure quality deliverables on-time and on-budget.
  • 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.
  • Develops site activation timeline.
  • Works with the study team to determine the Essential Document Package (EDP) requirements.
  • Completes templated documents with study specific information.
  • Coordinates and distributes the EDP to the clinical sites.
  • Tracks site identification and activation progress, identifies operations issues and escalates issues to the attention of the Project Manager.
  • Inputs study timelines and other required fields into the tracking system, monitors and updates fields as study timelines or other information changes.
  • Develops and maintains the site start up plan.
  • Assists with the development and maintenance of clinical study plans.

Requirements

  • At least four (4) years in pharmaceutical research field (CRO, pharma, site, etc.)
  • 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.
  • 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.
  • 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.
  • Proficient with Microsoft Office Suite.
  • Excellent presentation skills.
  • Strong organizational, problem-solving, and analytical skills.
  • Commitment to excellence and high standards.
  • Creative, flexible, and innovative team player.
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
site regulatory document collectionICF developmentsite contract negotiationbudget negotiationclinical study planssite activation timeline developmentEssential Document Package (EDP) requirementssite identification tasksoperations issue identificationstudy timeline tracking
Soft skills
independent judgmentwritten communicationverbal communicationmultitaskingorganizational skillsproblem-solving skillsanalytical skillsability to work under pressureteam playerflexibility