Jnj Careers – Associate Director Global Trial Leader

Job Summary

Johnson & Johnson currently has a vacancy for those looking to work as a Jnj Careers – Associate Director Global Trial Leader for Full Time at their offices in Titusville, NJ, US. Applicants should be sure to read the job outline attentively if they intend to apply.

Job Title:	Jnj Careers – Associate Director Global Trial Leader
Company Name:	Johnson & Johnson
Job Location:	Titusville, NJ, US
Job Type:	Full Time
Job Category:	Johnson & Johnson
Job Link Expiry:	2023-12-30
Posted on:	Jobinton.com

Job Details:

Job Description:

Janssen Research & Development, L.L.C., a member of Johnson & Johnson’s Family of Companies, is recruiting for an Associate Director Global Trial Leader MAO. The position is based in Titusville, NJ. Remote opportunities might be approved on a case-by-case basis.

Job Responsibilities:

• Manages risks and builds proposal for Action Plan(s) with the project team to implement solutions on a project level.
• Communicates and consults timely and regularly with the GPL
• Identifies and proactively manages issues in a timely manner.
• Mentors and coaches other GTLs or TLs.
• Tracks project progress against planned timelines. Monitors patient enrolment at global and or regional level. Ensures timely and accurate documentation and communication of project progress. Based on evolution of progress, initiates corrections to impacted operations.
• Single point of accountability for end-to-end operational management of the assigned programs
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for program management (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements where applicable.
• Escalates issues to appropriate team members
• May be delegated to provide oversight or act as the Line Manager for GTLs, TLs and/or G-CTAs responsible for performance management, coaching and development planning.
• This includes forecasting and pro-active management of program specific budgets
• Maintains project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes. Ensures quality oversight of assigned projects utilizing the available tools so that the project is in a constant state of inspection-
• readiness. Participates in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits.
• Is accountable for delivery of assigned programs within agreed budget. Ensures accurate program budget management and reconciliation of assigned projects for both Out of Pocket (OOP) costs and FTE costs. Responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
• Provides regular status updates to the project team, project owners and Clinical Team / Medical Affairs members. Ensures required reports are generated and available for real time tracking of project status.
• The AD GTL contributes to or leads (cross-) functional process initiatives
• Ensures correct and timely reporting AEs/SAEs/PQCs, as appropriate.

Job Requirements:

• Bachelor’s degree or equivalent required, preferably in Life Sciences.
• Project management skills and proficient communication skills are required.
• Specific therapeutic area experience may be required depending on the position.
• Minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol specific procedures is required.

Job Details:

Company: Johnson & Johnson

Vacancy Type: Full Time

Job Location: Titusville, NJ, US

Application Deadline: N/A

Apply Here

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