Operations Recruitment Manager (1 of 2)

Job description

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Operations Recruitment Manager to be preferably based in either Spring House PA, Horsham PA, Raritan NJ, Malvern, PA, or Titusville NJ or based remotely in the United States and may require up to 20% domestic and international travel.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com for more information.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Operations Recruitment Manager 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.). Tactics include, but are not limited to: patient recruitment, retention or compliance; Informed Consent; or patient or site engagement.

This position acts as the interface with key GCDO Portfolio Delivery Organization (PDO) customers Global Trial Leaders (GTL), Clinical trial Managers (CTM), 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 in vTMF, as well as maintaining documentation of business processes and quality standards for effective tactic development. As an Operations Recruitment Manager responsibilities include:

· Develop a SOW in alignment with the Strategic Recruitment Plan for the indication or compound
· Develop a Project Plan based on the SOW for delivery of the tools and tactics for a clinical trial
· Manage execution phase of project is required
· Contracting with vendors, as defined in SOW, with the help of Janssen R&D Procurement (JRP) and once a contract is obtained, secure PO is required
· 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 is required
· Oversee the translations of tools and tactics as listed in the SOW is required
· Facilitate the applicable central J&J compliance review process of tools and tactics; obtain and document the compliance approvals
· Ensure 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.
· Responsible for managing timelines to meet the local submission process
· Track the costs of the vendors involved and provide regular spending updates to the Program Manager and study teams
· Maintaining close communications and updates to Program Manager
· Responsible for understanding and applying Janssen finance and contracting systems
· Execute different scenarios in recruitment tools and tactics management: amendments, rescue situations, 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 in vTMF and the PARiS SharePoint, as well as FAQs regarding the deliverables
· Maintain documentation of development and implementation requirements to ensure quality standards are met
· Provide metrics needed for ROI and KPI evaluation to the Operations Lead, PARIS
· Development of Master Informed Consent Form

Desired profile

Qualifications :

·  A minimum of a Bachelor's Degree is required
·  At least 3 years experience in patient recruitment, clinical trial execution with a pharmaceutical company, CRO, and/or healthcare facility/research site is required
·  Expertise in the areas of drug development, clinical trial operations, and strategic planning is required
·  Experience in clinical trial operations including the execution of study outreach, patient compliance and study support programs is required
·  Experience presenting at an Investigators Meetings is preferred
·  Ability to manage study team, study timeline, vendors and budget is preferred
·  Strong project management skills and the ability to manage multiple projects is required
·  Demonstrates initiative to solve problems and improve efficiency and/or customer service is required
·  High-degree of proficiency in Microsoft Excel, PowerPoint and Word is required
·  Microsoft Project preferred