Clinical Trial Manager
Johnson & Johnson
2 dagen geleden

Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time.

From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are handled, interpreted, and prevented.

We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases.

We seek not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines : the best available treatment at an affordable price.

That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.

You will be responsible for the regional / global coordination of clinical trial management activities for internally run and / or outsourced trials.

He or she streamlines and channels communication with the countries.

Duties / Responsibilities :

  • Leading the Study Management Team (SMT), drives issue resolutions, and provides updates to all Trial Team members on results.
  • Ensuring required reports are generated and available for real time tracking of trial status.
  • Contributing to data collection to support the site selection process
  • Establishing enrolment commitments and ensure actual enrolment meets projected commitments across the regions at the clinical trial level.
  • Ensures the availability of robust recruitment / contingency plans are in place for each region

  • Ensuring timely and accurate documentation and communication of study progress and issue escalation.
  • Building, updating and improving study-specific documents such as Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents.
  • Provide input into cross-functional documents such as Safety related documents, Protocol Deviations and critical issue processes, External Service Provider Oversight Plan, Filing and Archiving Plan.

  • Planning and coordinating Investigator Meetings
  • Ensuring creation of appropriate trial-specific training materials and requirements, making them available to the regional / site / CRO staff and delivering training as needed.
  • Acting as the primary contact person for the local teams within GD. Establish and maintain excellent working relationships with internal partners, such as country representatives, data management leader and clinical supply unit.
  • Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge
  • Coordinate data cleaning with some supervision towards a timely and successful database lock
  • Qualifications

    Do you meet the following education and experience Requirements?

  • BS degree or equivalent
  • Extensive clinical trial operations experience in the pharmaceutical industry or CRO.
  • Clinical research operational knowledge, strong project planning / management expertise and effective communication skills.
  • Able to coordinate global or regional teams in a virtual environment. Proven track record in successfully running various aspects of trials from start-up to database lock.
  • Effective leadership skills and ability to manage multiple partners.
  • Proven experience in presenting to partners. Consistent track record to foster team efficiency and cohesiveness. Strong decision making, solution oriented.
  • Solid understanding of standard Microsoft applications, ability to learn new systems.
  • 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.

    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.

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