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Beerse, BE

The Global Trial Manager (GTM) - Early Development Oncology-000009SM

Omschrijving

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for an ED Oncology Global Trial Manager position. The position can be located in any location, with preference to one of the headquarters.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Global Trial Manager (GTM) will be accountable for the successful execution of global clinical trials assigned by the Clinical Program Leader (CPL) with a focus on early development oncology. This position is responsible for the operational management of the ED oncology study and will work very closely with the study physician/scientist. The person will be responsible for resource allocation within agreed timelines and budget, with high quality and meeting all the SOP and regulatory requirements. Additionally, the Global Trial Manager will lead the study management team, cross-functional working group meeting and be required to align their goals with organizational objectives as defined in the Global Clinical Operations (GCO) cascades.

The Global Trial Manager is considered the owner of the clinical study and will lead the Study Management Team concentrating on trial management supervision, planning and coordination. Some of the responsibilities will include trial set-up and execution, review of monitoring visit reports, budget management, patient recruitment/retention, database closure oversight, and clinical supplies management associated with each trial. The Global Trial Manager will also measure progress against goals to achieve clinical research targets, ensuring that the commitments meet the actuals across the regions at the trial level. This position will also be responsible for monitoring patient recruitment on a global scale as well as ensuring timely and accurate documentation and communication of study progress and issues.

Additionally, the Global Trial Manager will be responsible for increasing the productivity for all of their assigned clinical trials, contribute to an effective ED organization and to optimize the relationship with R&DC. The Global Trial Manager will ensure required reports are generated and compliance with US and global regulatory agencies. The Global Trial Manager will also need to prepare for and conduct FDA and internal QA inspections.

Kwalificaties
- A minimum of a Bachelors degree or equivalent is required, preferred in Life Sciences.
- A minimum of 5 years experience with clinical trials in the pharmaceutical industry and/or a CRO is required.
- At least 3 years of experience within oncology and/or early development is highly desired. Experience in oncology ED studies is a plus.
- Experience managing and executing clinical trials is required. Experience managing global clinical trials is preferred. Experience managing CROs is preferred.
- Strong operational expertise, project planning, strong organization skills, excellent decision-making and strong financial management skills are required.
- Effective leadership skills and the proven ability to foster team productivity and cohesiveness is highly desired.
- Excellent communication skills coupled with the innate flexibility to work in a rapidly growing organization is required.
- This position may have up to 20% domestic and international travel.

Primaire locatie: Europa/Midden-Oosten/Afrika-België-Antwerpen-Beerse

Organisatie: Janssen Pharmaceutica N.V. (7555)

Functie: R&D