Trial Manager MAO

Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Trial Manager Medical Affairs Operations (MAO) to be located in Titusville, NJ,  but there is potential for remote opportunities. Remote work options may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Global Services LLC is part of the Janssen Pharmaceutical Companies.

Position Overview:

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, Functional Manager, or Operations Head.

This includes 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), according to planned milestones, within budget, and with high quality standards per company procedures and regulatory requirements.

• Serves 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, GD functions, stakeholders from local Medical Affairs or other internal trial sponsors, external service providers e.g. contract research organization (CRO) and/or other J&J enterprise sectors, as applicable.
• Responsibilities include but are not limited to project activities starting from protocol development to delivery of final Clinical Study report (CSR) or other deliverable(s), as well as driving 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

Key Responsibilities:

1. 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.

2. Prepare or contribute to high level budget estimate in response to Request for Services followed by detailed budget proposal.

3. Lead vendor assessment and selection in consultation with appropriate representatives of the operating company.

4. Ensure accurate project budget management and tracking according to plan. Update project account with scope changes, if any.

5. 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. Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.

6. Track project progress against planned timelines and monitor patient recruitment rate to ensure that target enrolment will be met across the allocated regions/countries.

7. 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.

8. In coordination with the Functional Manager/GPL, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, provide adequate project-specific training to the GCO or CRO teams and to the site staff. Works with GCO/CRO staff in the set-up and coordination of Investigator Meetings, if applicable.

9. Maintain project compliance within all applicable Health Authority (HA) regulations, guidelines, internal 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.

10. Identifies and proactively manages 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.

Qualifications

• Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 5 years of clinical trial experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Clinical operations knowledge, project management and proficient communication skills are required. Computer literacy is also required.
• Excellent decision-making and strong financial management skills are essential for this position.
• Effective study team leadership skills and proven ability to foster team productivity and cohesiveness. Flexibility and ability to manage study teams in a virtual environment are needed.
• Ability to work on multiple projects in parallel in different therapeutic areas is required.
• Experience in managing all study types (interventional, non-interventional, registries) is preferred.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

The anticipated base pay range for this position is $88,000 to $123,500.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.  

For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

 

 

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
2105994378W

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