Associate Local Trial Manager

Johnson & Johnson is currently seeking an Associate Local Trial Manager to join our Global Clinical Operations team located in Beerse, Belgium or Breda, the Netherlands. This is a hybrid role and office presence twice a week is required.

We are looking for a driven Associate Local Trial Manager (LTM) to report to the Clinical Research Manager (CRM), running assigned clinical trials (phases 1b-2-3) in the Netherlands and in Belgium. You will have operational oversight of assigned protocols from start-up through to database lock/ closure of the trial. You will be responsible for coordinating and leading the local trial team to deliver quality data and trial documents that are aligned with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory standards.

The LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA) and Site Managers (SM) roles. The LTM may have some site management responsibilities.

You need a flexible mindset and have the ability to work in a fast-changing environment. You will be part of a hardworking, enthusiastic, and committed team of +100 people eager to deliver and helping to improve the lives of millions of patients.

Principal Responsibilities:

Collaborate with the Manager Clinical Operations (MCO) for feasibility assessment. Set predictable and realistic start up time lines. Lead and coordinate trial activities and project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Act as subject matter expert for assigned protocols. Develop strong therapeutic knowledge to support roles and responsibilities. Act as primary country contact for a trial. Establishes and maintains excellent working relationships with external organisations and internal partners, including Medical Affairs. Encourage and empower trial teams to deliver on the trial commitments. Keep patient engagement and safety central to all activities. Contribute and encourage process improvement at every opportunity.

Education and Experience Requirements

• A minimum of a BA or BSc degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
• You have gained experience in clinical trials and preferably in site monitoring and have experience of project management tasks.
• Ability to travel with occasional overnight stay away from home.
• Drivers license B required.
• You have proven leadership, communication and digital literacy.
• The ability to lead initiatives/small teams.
• Proficient in Dutch, French and English for Belgium based candidates, Dutch and English for candidates based in the Netherlands

Preferred Skills:

Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethic