10 nov
|
Johnson & Johnson
|
Madrid
10 nov
Johnson & Johnson
Madrid
Job FunctionR&D; Operations
Job Sub FunctionClinical Trial Project Management
Job CategoryProfessional
Job Locations
Beerse, Antwerp, Belgium
Madrid, Spain
Milano, Italy
Warsaw, Masovian, Poland
Job DescriptionThe 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 RequirementsBS degree or equivalent. 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.
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 integral 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.
Additional Requirements
Travel up to 15-20% of the time, defined by business needs.
Preferred related industry experience: Pharmaceutical, Biopharmaceutical, Biotechnology.
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).
Pay RangePrimary posting location: €72,500.00 - €115,230.00. Additional location ranges: Spain — 55,400 EUR – 87,860 EUR;
Italy — 48,600 EUR – 77,395 EUR;
Poland — 210,000 PLZ – 402,500 PLZ.
BenefitsIn addition to base pay, we offer an annual bonus with set target (%) of pay depending on pay grade/location, 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, service anniversary and recognition awards, and, where applicable, insurance plans for employees and eligible dependents. 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.
📌 Lead, Trial Delivery Management (Madrid)
🏢 Johnson & Johnson
📍 Madrid