Janssen research and development, l.l.c., a member of johnson and johnson`s family of companies, is recruiting for an operations recruitment managerThe position is located in titusville, nj or can be remote for the right us based candidate.
At the janssen pharmaceutical companies of johnson & johnson, we are working to create a world without diseaseTransforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires usWe bring together the best minds and pursue the most promising scienceWe are janssenWe collaborate with the world for the health of everyone in itLearn more at www.janssen.com and follow us @janssenglobalJanssen research & development, llc is part of the janssen pharmaceutical companies.
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.) 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 tacticsThis position is responsible for maintaining the library of tools and tactics invtmf, as well as maintaining documentation of business processes and quality standards for effective tactic development.
Principal responsibilities:
Develop an sow in alignment with the strategic engagement 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:
Including contracting 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
Ensureirb/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, rescuesituations , added countries and sites, adaptive design, non template requests, as defined in the updated sow.
Serve as the point of contact and sme between the clinical trial team and suppliers, as appropriate.
Participate in critical study-related meetings, i.e., study management team (smt) meetings, cross-functional team meetings (cftm), etc.
Escalate implementation issues as defined by the departmental business processes
Maintain a library of tools, tactics and templates in vtmf and the ci&e/ipe sharepoint site
Maintain documentation of development and implementation requirements to ensure quality standards are met
Provide metrics needed for roi and kpi evaluation to the operations recruitment lead,
Development of informed consent forms and implementation of econsent
Develop and deliver presentations and workshop content at international investigator meetings, ad hoc face-to-face meetings, and other similar meetings.
Qualifications
Bachelor’s degree or equivalent, preferably in a scientific or health-related discipline.
At least 3 years of relevant experience in global patient recruitment or clinical trial execution with a pharmaceutical company or cro, and/or healthcare facility/research site.
Knowledge 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 skillsStrong 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 wordMicrosoft project preferred.
Johnson & johnson is an affirmative action and equal opportunity employerAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary location
United states-new jersey-titusville-1125 trenton harbourton road
Other locations
North america-united states
Organization
Janssen research & development, llc (6084)
Job function
R&d
Requisition id
2105970429w
