Lead, Trial Delivery Management

Leiden Bio Science Park; Leiden; On-site; EUR 90,000 - 140,000; Full time

Job summary

Leiden Bio Science Park is seeking a Lead, Trial Delivery Management to oversee study-level execution, document control, and vendor oversight across country/regional delivery. You will align feasibility, set targets, perform risk reviews, and address local challenges impacting study delivery.

The role requires 4+ years in clinical trials, strong leadership, and collaboration across global teams. Travel up to 15–20% is expected, with opportunities to mentor new staff and support inspections.

Qualifications

• BS degree or equivalent in Life Sciences.
• Minimum 4 years clinical trial experience in pharma/healthcare.
• Experience across multiple study phases (I–IV).
• 2–3 years supporting global clinical trials.
• Strong leadership and mentoring abilities.
• Ability to work with limited supervision.
• Travel 15–20% as required.

Responsibilities

• Create and update critical trial-specific documents (e.g., Monitoring Guidelines, ICF, IMP-related documentation).
• Manage vendor setup and day-to-day vendor activities including SOW creation and budget oversight.
• Coordinate country/regional trial management activities and oversight with local teams.
• Support development of program-level compound training with Clinical / CTL&D / Medical writing.
• Provide input into trial level operational strategies and risk reviews.
• Resolve trial-related issues and mitigate risks; participate in process improvements.
• Mentor onboarding of new team members and support inspections when needed.

Skills

Leadership

Project management

Communication

Risk management

Vendor management

Cross-functional collaboration

Mentoring

Analytical thinking

Strategic planning

Budget oversight

Education

Bachelor's degree in Life Sciences

Tools

CTMS

Job description

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) RequiredYears 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)