TRIAL MANAGER - MEDICAL AFFAIRS OPERATIONS (1 OF 2)

DescriptionJanssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Trial Manager - Medical Affairs Operations. This position can be located remotely within the United States.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. And we pursue the most promising science, wherever it might be found.Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.The Trial Manager - Medical Affairs Operations (MAO) will be accountable for leading the execution of local company data generation activities in one or more countries for project(s) assigned by the Global Program Leader (GPL), Functional Manager, or Operations Head. This will include all project activities starting from Request for Services and high-level budget estimate through protocol development to delivery of final Clinical Study Report (CSR) or other deliverable(s). In addition, drive issue identification and resolution and contingency planning, all according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements.The Trial Manager will serve as the single point of end-to-end accountability for assigned project(s); leads the Study Management Team (SMT) for local studies, interfaces with the Clinical Teams, Global Development (GD) functions, stakeholders from local Medical Affairs or other internal trial sponsors, external service providers (e.g., contract research organization (CRO) and/or other Johnson & Johnson enterprise sectors, as applicable).Principal Responsibilities: Lead the SMT as the single point of accountability for end-to-end project management, including high level budget estimate, protocol development, trial set-up, execution, close-out, analysis and reporting.For projects executed in-house, oversee and support Site Managers, GCO-LTM (if assigned) and other team members in the daily operational activities in line with country specific regulations and internal processes, if required.For projects outsourced to a CRO, oversee and monitor the CRO’s performance on all contracted services.Prepare or contribute to high level budget estimate in response to Request for Services followed by detailed budget proposal.Lead vendor assessment and selection in consultation with appropriate representatives of the operating company.Ensure accurate project budget management and tracking according to plan. Update project account with scope changes, if any.Accountable for delivery of assigned trials within agreed/projected life of trial budget. Ensure accurate trial budget management and tracking, updates for scope changes and reconciliation of costs, as applicable. Overall contract management, including review and approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.Track project progress against planned timelines and monitor patient recruitment rate to ensure that target enrolment will be met across the allocated regions/countries.Provide regular status updates to SMT, project owners and Clinical Team members. Ensure required reports are generated and available for real time tracking of project status.In coordination with the Functional Manager/GPL, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, provide adequate project-specific training to the Global Clinical Operations (GCO) or CRO teams and to the site staff. Work with GCO/CRO staff in the set-up and coordination of Investigator Meetings, if applicable.Maintain project compliance within all applicable Health Authority (HA) regulations, guidelines, internal Standard Operating Procedures (SOPs) and processes. Ensure quality oversight of assigned projects utilizing the available tools so that the project is in a constant state of inspection-readiness. Participate in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits.Identify and proactively manage issues in a timely manner by communicating regularly with the Functional Manager/CPL/COH; escalating issues and managing risks related to resources, timelines and budgets. Build proposal for Action Plan(s) with the SMT to implement solutions on a project level.QualificationsA minimum of a Bachelor’s degree is required, preferably in a Life Science discipline (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).A minimum of 2 years of clinical trial experience within the pharmaceutical industry, Contract Research Organization and/or investigational site is preferred.Knowledge of clinical operations is required.Experience managing all study types (interventional, non-interventional, registries) is preferred.Project management experience is required.Strong computer skills in appropriate software applications and related clinical systems required.Financial management skills required.Must have excellent oral and written communication skills.Must have strong problem-solving and decision-making skills.Effective study team leadership skills with the proven ability to foster team productivity and cohesiveness is required.The ability to manage study teams in a virtual environment is preferred.The ability to work on multiple projects in parallel in different therapeutic areas is required.Minimal business travel (meetings, training, etc.) is required.The anticipated base pay range for this position in the San Francisco Bay Area, CA is $119,000 to $191,820.The anticipated base pay range for this position in all other U.S. locations is $104,000 to $166,750.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Employees are eligible for the following time off benefits:Vacation - up to 120 hours per calendar yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar yearHoliday pay, including Floating Holidays - up to 13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearFor additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThis job posting is anticipated to close on February 13, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All 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.Job Field: Clinical Trial Project ManagementOrganization: Janssen Research & Development, LLC (6084)