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Operations Recruitment Manager - Patient Recruitment & Site Support

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About the role

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Operations Recruitment Manager - Patient Recruitment & Site Support
 

The position is primarily accountable for the management, execution and timely delivery of tactics for patient and site-facing initiatives for a clinical trial as defined in the Statement of Work (SOW) developed by the Strategic Recruitment Manager. Tactics include, but are not limited to: patient recruitment, retention or compliance; Informed Consent; or site engagement.
This position acts as the interface with key GCO customers (Global Trial Manager (GTM), Local Trial Manager (LTM) and Site Manager (SM)), suppliers, and other stakeholders involved in the development, management, and dissemination of patient and site-facing tactics.
This position is responsible for maintaining the library of tools and tactics on the GCO portal, as well as maintaining documentation of business processes and quality standards for effective tactic development.

 
Roles & Responsibilities of the position
 

 
Develop a Project Plan based on the SOW for tools and tactics for a clinical trial as developed by the Strategic Recruitment Manager.
  • Manage execution phase of project:
  • Go to contract with vendors, as defined in SOW, with the help of Janssen R&D Procurement (JRP) and once a contract is obtained, go to PO
  • Provide the development of tools and tactics as listed in the SOW, including the content writing or the liaising with a vendor for content writing
  • Oversee the translations of tools and tactics as listed in the SOW
  • Facilitate the applicable central J&J compliance review process of tools and tactics; obtain and document the compliance approvals
  • Obtain and document local approval of tools and tactics by the local trial team
  • Obtain and document IRB/EC approval of tools and tactics, if needed
  • Manage the execution or the printing and distribution process of the approved tools and tactics
  • Manage the vendors involved, set clear expectations with the vendor regarding deliverables, timelines, costs, communication pathway, etc.
  • Control the timelines to meet the local submission process
  • Track the costs of the vendors involved and provide regular spending updates to the Strategic Recruitment Manager.
  • Execute different scenarios in recruitment tools and tactics management: amendments, rescue missions, added countries and sites, adaptive design, non-template requests, as defined in the updated SOW.
  • Serve as the liaison between the clinical trial team and suppliers, as appropriate.
  • Participate in critical study-related meetings, i.e., Study Management Team (SMT) meetings
  • Escalate implementation issues as defined by the departmental business processes
  • Maintain a library of tools, tactics and templates on the GCO portal, as well as FAQs regarding the deliverables
 
Job Requirements
  • At least 3 years of relevant experience in clinical trial execution with a pharmaceutical company and/or a CRO.
  • Expertise in the areas of drug development, clinical trial operations, and strategic planning.
  • Previous experience in clinical trial operations including the execution of study outreach, patient compliance and study support programs.
  • Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of successfully managing multiple projects.
  • Excellent time, priority, and self management skills. Strong project management skills.
  • Strong team orientation; demonstrates initiative to solve problems and improve efficiency and/or customer service.
  • High-degree of proficiency in Microsoft Excel, PowerPoint and Word.
 

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