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Lead, trial delivery manager, established products (4 openings) (madrid)

Madrid
Johnson & Johnson Innovative Medicine
Delivery manager
Publicada el 26 noviembre
Descripción

About Johnson & Johnson

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. Learn more at

Job Details

Job Function: R&D; Operations
Job Sub Function: Clinical Trial Project Management
Job Category: Professional
All Job Posting Locations: Beerse, Antwerp, Belgium; Madrid, Spain

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

Requisition Information

This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.
United States – Requisition Number: R-
Belgium and Spain – Requisition Number: R-
United Kingdom – Requisition Number: R-
Switzerland – Requisition Number: R-

Lead, Trial Delivery Manager (TDM)

Position: Lead, Trial Delivery Manager, Established Products (4 openings). Location: Beerse, Belgium or Madrid, Spain. This is a hybrid position and requires you to be onsite 3 days a week.

Purpose

The Lead, Trial Delivery Manager (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).
- Manage vendor set up and day‑to‑day study vendor activities, including set‑up, SOW creation and budget oversight.
- Coordinate trial management activities and oversight at country/regional level, align feasibility strategy with local teams, perform country‑level risk reviews, and be 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 help identify risks and mitigation plans at the program level for key issues.
- Mentor and support onboarding of new team members, particularly those in Trial Management.

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

- Bachelor’s degree required; preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- 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 general clinical trial.
- A minimum of one year experience with Phase II or III registrational clinical trial experience.
- Excellent leadership skills and proven ability to foster team productivity and cohesiveness.
- Experience leading without authority and in multi‑functional matrixed and global environments.
- Excellent decision‑making, analytical and strong financial management skills essential.
- Operate and execute with limited supervision.
- Experience mentoring/coaching others.
- Strong project planning/management, communication and presentation skills required.
- Travel up to 15‑20% of the time, defined by business needs, domestic and/or international.

Required 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).

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).

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