Lead, Trial Delivery Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Toronto Ontario Canada

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

Beerse Belgium Milano Italy Madrid Spain Warsaw Poland - Requisition Number: R-082397

High Wycombe United Kingdom - Requisition Number: R-084375

Spring House PA United States - Requisition Number: R-084378

Toronto Canada - Requisition Number: R-084381

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

The Lead 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.

Principal Responsibilities:

• Create and update critical trial-specific documents (e.g. Monitoring Guidelines Informed Consent Form Investigational Medicinal Product IMP related documentation).

• Manage 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.

Education and Experience Requirements:

BS degree or equivalent preferred areas of study include Life Sciences (Life Sciences (e.g. Biology

Chemistry Biochemistry Nursing Pharmacy) Required Years of Related

Minimum of 4 years clinical trial experience in Pharmaceutical Healthcare or related industries.

Required Knowledge and Experience:

• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.

• 2-3 years experience supporting multiple aspects of a global clinical trial.

• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.

• Experience 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.

Other:

Percentage Traveled:

Travel up to 15-20% of the time defined by business needs.

Preferred Related Industry Experience:

Pharmaceutical Biopharmaceutical Biotechnology

Required Skills:

Preferred Skills:

Analytical Reasoning Clinical Research and Regulations Clinical Trial Designs Clinical Trial Management Systems (CTMS) Clinical Trials Communication Data Savvy Laboratory Operations Organizing Problem Solving Productivity Planning Professional Ethics Project Integration Management Quality Assurance (QA) Regulatory Compliance Research and Development Research Ethics Standard Operating Procedure (SOP)
Employment Type : Full-Time
Experience: years
Vacancy: 1