Job Information
J&J Family of Companies Senior Local Trial Manager in North Brabant, Netherlands
Senior Local Trial Manager - 2406182759W
Description
We are looking for a driven Senior Local Trial Manager (LTM) to report to the Clinical Research Manager (CRM), running assigned clinical trials (phases 1b-2-3) in Belgium (Beerse) and The Netherlands (Breda). 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), Site Managers (SM) and Local Trial Manager (LTM) roles. The LTM may have some site management responsibilities.
You need a flexible mindset and have the ability to work in a constantly evolving environment. You will be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.
Principal Responsibilities:
Collaborate with the CRM for protocol and site feasibility assessment. Implement consistent pre-trial assessment visit approach. Set predictable and realistic start up time lines.
Lead and coordinate local trial activities and project planning activities to meet site open and recruitment targets and to deliver high quality data on time and within study budget. Develop and install contingency plans in a proactive way and drive issue resolution in a timely matter.
Act as subject matter expert for assigned protocols. Develop strong therapeutic knowledge.
Act as primary country contact for a trial. Establishes and maintains excellent working relationships with external organisations and internal partners, including Medical Affairs.
Review and approve monitoring reports. Prepare country specific informed consent forms. Obtain country Ethics Committee and Health Authority approvals. Keep oversight or initiate of corrective and preventive actions.
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. Leads and/or participates in special initiatives as assigned. May assume additional responsibilities or special initiatives such as 'Champion' or ''Subject Matter Expert'.
Coach or mentor to less experienced colleagues.
Qualifications
Do you have the following Education and Experience we require?:
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 skills, effective communication skills and digital literacy.
The ability to lead initiatives/small teams.
Proficient in Dutch and English for candidates based in the Netherlands
Proficient in Dutch, English, and French for candidates based in Belgium
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Primary Location Europe/Middle East/Africa-Netherlands-North Brabant-Breda
Other Locations Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization Janssen-Cilag Netherlands (8345)
Travel Yes, 10 % of the Time
Job Function Clinical Trial Project Management
Req ID: 2406182759W