Lead, Trial Delivery Management

Johnson & Johnson; Milano; In loco; EUR 64.000 - 103.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson in Milano, Italy seeks a Clinical Trial Project Manager within R&D Operations to lead cross-country trial activities, vendor management, and country-level coordination to ensure timelines, quality, and regulatory compliance.

The role requires a BS in Life Sciences, 4+ years in clinical trials, strong leadership, and ability to collaborate across global teams with up to 15–20% travel.

Competenze

• BS degree or equivalent in Life Sciences.
• Minimum 4 years clinical trial experience in pharmaceutical, healthcare or related industries.
• Experience across multiple phases of studies (Phase I-IV) with ability to manage trial execution.
• 2-3 years’ experience supporting multiple aspects of a global clinical trial.
• Strong leadership skills and ability to work in global, matrixed environments.

Mansioni

• Create and update trial-specific documents (Monitoring Guidelines, ICF, IMP files).
• Manage vendor setup and day-to-day study vendor activities.
• Coordinate country/regional trial management activities and risk reviews.
• Support development of program-level training with CTL&D/Medical writing.
• Provide input into trial-level operational strategies.
• Resolve trial-related issues and mitigate risks.
• Participate in process improvements at trial/compound level.
• Support Health Authority inspections and risk mitigation planning.

Conoscenze

Analytical Reasoning

Clinical Research

Regulatory Compliance

Clinical Trial Designs

CTMS

Clinical Trials

Communication

Data Savvy

Laboratory Operations

Organizing

Problem Solving

Productivity Planning

Professional Ethics

Project Integration Management

QA

SOP

Research and Development

Research Ethics

Formazione

BS degree or equivalent in Life Sciences

Strumenti

CTMS

MS Office

Descrizione del lavoro

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

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

Beerse, Antwerp, Belgium, Breda, Netherlands, Madrid, Spain, Milano, Italy, Warsaw, Masovian, Poland

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 https://www.jnj.com/innovative-medicine

Please 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):

• High Wycombe, United Kingdom - Requisition Number: R-096653
• Spring House, PA, Titusville, NJ United States - Requisition Number: R-098245 Beerse, Belgium, Breda, Netherlands, Warsaw, Poland, Madrid, Spain, Milan, Italy - Requisition Number: R-098254
• Beerse, Belgium, Breda, Netherlands, Warsaw, Poland, Madrid, Spain, Milan, Italy - Requisition Number: R-098254

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

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.
• 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.
• Travel up to 15-20% of the time, defined by business needs.
• Preferred Related Industry Experience: Pharmaceutical, Biopharmaceutical, Biotechnology

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)

The anticipated pay range for this position, in the primary posting location, is:

€64,000.00 - €103,040.00

The anticipated pay ranges for additional locations are:

• Spain – The anticipated base pay range for this position is 55,400 – 87,860 EUR
• Italy – The anticipated base pay range for this position is 48,600 – 77,395 EUR
• Poland – The anticipated base pay range for this position is 210,000 – 402,500 PLN
• Belgium – The anticipated base pay range for this position is 72,500 – 115,230 EUR

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.