Manager, Trial Delivery Management Cross Therapeutic Area

Manager, Trial Delivery Management Cross Therapeutic Area

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

We are searching for the best talent for a Manager, Trial Delivery Management Cross Therapeutic Area, to be located remotely in the United States.

Purpose :

The Manager, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery.

You Will Be Responsible For :

• Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
• Vendor set up and management of day-to-day study vendor activities, including set-up, SOW + creation and budget oversight.
• Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
• Support development of program-level compound training, collaborating with Clinical / CTL&D Medical writing.
• Provide input into trial level operational strategies.
• Resolve trial-related issues and mitigate trial-related risks.
• Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
• Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Mentor & support onboarding of new team members, particularly those in Trial Management.
• Foster employee engagement, inclusion, and Credo Behaviors.

Principal Relationships :

Internal : Trial Management Directors, Clinical Trial Leaders, Clinical Trial Assistants, Representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams, representatives of Procurement.

External : Vendors

Qualifications / Requirements :

A minimum of a BS degree or equivalent, preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). A minimum of 8 years in Pharmaceutical, Healthcare or related industries. Experience in and knowledge of the pharmaceutical development process. Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV) must have the ability to manage all aspects of execution of a clinical trial. 2-3 years' experience leading multiple aspects of a global clinical trial. Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness. Experience of leading without authority and in muti-functional matrixed and global environments. Excellent decision-making, analytical and strong financial management skills are essential to this position. Operate and execute with limited supervision. Experience mentoring / coaching others. Strong project planning / management, communication and presentation skills are required. Travel up to 15-20% of the time, defined by business needs.

The anticipated base pay range for this position is $115,000 to $197,800. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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 year; Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year; Holiday pay, including Floating Holidays - up to 13 days per calendar year; Work, Personal and Family Time - up to 40 hours per calendar year.

Required Skills :

Preferred Skills :

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https : / / www.jnj.com / contact-us / careers, internal employees contact AskGS to be directed to your accommodation resource.