Lead, Trial Delivery Management

Get 360Pharma; Beerse; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Get 360Pharma seeks a Lead, Trial Delivery Management to oversee country and regional trial delivery, document creation, vendor oversight, and risk management across studies. The role requires coordinating feasibility, risk reviews, and local challenges to ensure timely study delivery.

You will mentor teammates, contribute to program-level training, and support inspections and process improvements to enhance operational performance across trials.

Qualifications

• BS degree in Life Sciences or related field.
• Minimum 4 years clinical trial experience in Pharmaceutical or Healthcare industries.
• Experience across multiple phases I–IV; ability to manage multiple aspects of trial execution.
• Strong leadership, budgeting, and cross-functional collaboration skills.
• Willingness to travel 15–20% as required.

Responsabilités

• Create and update critical trial-specific documents (e.g., Monitoring Guidelines, ICF, IMP documentation).
• Manage vendor setup and day-to-day oversight, including SOWs and budgets.
• Coordinate country/regional trial management activities and align feasibility strategies.
• Support program-level compound training with Clinical/CTL&D/Medical Writing.
• Provide input into trial-level operational strategies and issue/risk mitigation.
• Mentor and onboard new team members; participate in process improvements.
• Support Health Authority inspections and risk mitigation planning at the program level.

Connaissances

Leadership

Project management

Analytical thinking

Communication

Problem solving

Mentoring

Stakeholder management

Formation

BS degree in Life Sciences or related field

Outils

CTMS

Microsoft Office

Regulatory databases

Description du poste

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)