Manager, Trial Delivery Management

Leiden Bio Science Park; Leiden; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Leiden Bio Science Park seeks a Manager, Trial Delivery Management to oversee study-level activities, document creation, and vendor oversight for country/regional trial execution.

You will align feasibility strategies, lead risk reviews, and ensure program-level training with clinical writing teams.

Qualifications

• BS degree in Life Sciences or related field and relevant experience in pharmaceutical/healthcare contexts.
• Minimum 8 years in pharmaceutical, healthcare or related industries.
• Experience in and knowledge of the pharmaceutical development process.
• Clinical research operations knowledge across multiple phases (Phase I-IV) and ability to manage all aspects of trial execution.
• 2-3 years’ experience leading multiple aspects of a global clinical trial.

Responsibilities

• Create and update critical trial documents (Monitoring Guidelines, Informed Consent Form, IMP-related docs).
• Vendor setup and management of day-to-day study activities, including SOW creation and budget oversight.
• Coordinate country/region trial management activities and align feasibility with local teams.
• Develop program-level compound training and collaborate with Clinical/CTL&D Medical writing.
• Support trial strategy input and participate in process improvements at trial/compound level.
• Mentor new team members and foster team productivity and Credo Behaviors.

Skills

Leadership

Budgeting

Project management

Communication

Mentorship

Education

BS degree in Life Sciences

Tools

CTMS

MS Office

Job description

The Manager, 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).
• 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.

Additional Responsibilities may Include:

• 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 ManagementFoster employee engagement, inclusion, and Credo Behaviors.

Education and Experience Requirements:

• BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
• Minimum of 8 years in Pharmeceutical, Healthcare or related industries.
• Experience in and knowledge of the pharmaceutical development process.
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial.
• 2-3 years’ experience leading multiple aspects of a global clinical trial
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience of 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, Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Execution Focus, Fact-Based Decision Making, Laboratory Operations, Mentorship, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Standard Operating Procedure (SOP), Technical Credibility

Hybrid work