Clinical Project Manager (id 1823)

For one of the world’s leading R&D companies, we have a great opportunity for a Clinical Project Manager to manage Early Development and Phase II studies. Experience in working in a biology, biotechnology or a cell culture lab is an asset because vendor management of specialised labs is an essential part of the job. Please make yourself known.

MISSION: The CPM provides guidance and leadership to representatives of various internal and vendor functions involved in the initiation, conduct/execution and/or finalization of Early Development (ED) and Phase II studies. The CPM manages vendors who are specialized in Blood-PBMC processing and in T-cell response assays.

MAIN RESPONSIBILITIES:

Clinical study management of Early Development and Phase II studies.

Gives study-design related input/feedback, in collaboration with Disease Area Scientist(s) and other internal partners

Reports trial status, progression and operational issues to the Clinical Team

Participates in the identification and selection of clinical sites and Service Providers

Leads Site feasibility and vendor selection

Closely follows up on timely execution and finalization of contracts/work orders with sites and vendors

Coordinates and oversees study-related actions of the different individual vendor partners contributing to the study

Assures timely submission to Competent Authorities, before, during and after conduct of the study

Oversees interactions / organizes coordination meetings with external vendors involved in the study; coordinates and chairs the meetings as needed.

Assures escalation and documentation of issues (site issues, central issues etc.)

Develops, tracks and keeps oversight on study budget and keeps study budget within pre-agreed limits

Assures overall quality of the study and adherence to study protocol, GCP and applicable SOPs

Performs co-monitoring visits when desired/required

Ensures timely filing and archiving of study related documents (study binders) and electronic records (such as email correspondence)

Ensures cross-trial consistency in management and conduct of studies

Development, review and implementation of all relevant study documents.

 

Management of vendors (labs) specialized in Blood-PBMC processing

Negotiates terms & conditions and price, and contracts a vendor that manages a global network of Blood-PBMC processing labs in collaboration with Procurement

Co-supervises training and (re)qualification of (newly selected) labs, including dry runs / pilot studies and quality assessments

Co-audits labs within the global lab network

Supervises the logistical set-up and management (by the vendor) of shipments, storage and inventory of blood samples

Safeguards the application of one uniform PBMC Processing procedure.

 

Management of vendors (labs) specialized in T-cell Response Assays

Negotiates terms & conditions and price, and contracts a vendor that performs T-cell response assays in collaboration with Procurement

Follows up on the qualification of the Immune assays that will be applied in interventional studies

Supervises the logistical set-up and management (by the vendor) of storage of cryo-PBMC samples (Liquid Nitrogen) in the Immunology Lab

Organizes and supervises the statistical analyses of data generated in immune-lab

Ensures a final report is created by the vendor and shared with the Clinical Development Team as appropriate according to the pre-defined timelines

 

REQUIREMENTS:

Education and experience:

• Minimum Master in Life Science – such as pharmacy, biology, biotechnology, etc
• Experience in clinical study management
• Experience in early clinical development, with emphasis on Clinical Study Execution and Management
• Experience in working in a biology / biotechnology / cell culture lab, is an asset
• Teamwork experience
• Experience in working in a matrix-structured organization, is an asset

 

Knowledge of:

• Good Laboratory Practice, Good Clinical Practice and ICH Guidelines is a must
• Early Development, Phase I and Phase II environment, is a must
• Late Development, is an asset
• Immunology (scientific knowledge), is an asset
• Vaccine Development is an asset

 

Skills:

• Excellent project management /organizational/logistical skills
• Solid scientific reasoning skills
• Fluent in written and spoken English with good presentation skills
• Ability to identify priorities and work under pressure to meet deadlines
• Ability to advise, persuade and negotiate with external parties in a supportive and constructive fashion
• Located in Belgium