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Oud 22 februari 2019, 12:43
JohnHart JohnHart is offline
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Geregistreerd: 4 januari 2016
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Standaard Merus is offering career opportunity for a Clinical Trials Manager (Utrecht, NL)

Are you ready to join our fight against cancer?

The team:
The Clinical Development team is responsible for all of the clinical trials we conduct for our product candidates. Currently we have four product candidates in phase I/II studies in oncology, most of them first in class compounds.

The role:

As a Clinical (Trials) Manager, your main tasks and responsibilities are the following:

• Ensure all operational trial deliverables are met according to timelines, budget, operational procedures, quality/compliance and performance standards under management of the Director of Clinical Trials. This includes the management of Contract Research Organizations (CRO’s);
• Assist in authoring protocol and related documents, development of study tools, guidelines and training materials;
• Manage clinical study material, oversee vendors and other third parties and assist in the implementation of issue resolution plan(s);
• Conduct regular thorough clinical data review to ensure it is consistent and valid and oversee cleaning activities by assigned CRO’s;
• Drive enrollment and recruitment activities and initiatives
• Support the development, management and tracking of trial budgets with the appropriate partners internally and externally;
• Lead Clinical Trial Team (CTT) meetings and draft meeting minutes under the supervision of the Director of Clinical Trials;
• Participate in the organization and logistics of various trial-related committees;
• Manage site-related issues and procedural questions, support Director of Clinical Trials in development of Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review reports and trial statistical analysis;
• Assist with program level activities (e.g., development of clinical sections of regulatory documents such as Investigators’ Brochures, DSUR/PSUR, IND/NDA submission documents) and provide support, as needed, for HA and/or IRB/IEC inquiries.

Our offer: We offer a competitive salary and flexible working hours. Our talented international team works in an inspiring area of Utrecht (Utrecht Science Park) in a brand new state-of-the-art facility. We also offer an excellent pension scheme, company bonus, and 30 days’ annual holiday based on a full-time position. We care about team spirit and organize several company events each year.

Merus: Working at Merus provides you with opportunities to grow and develop a career that offers both individual and company success. You will have the chance to make an impact within the oncology field by helping to develop bispecific antibody therapies (Biclonics®) to fight cancer. Merus’ headquarters are located in the Netherlands, but we also have offices in the US and many collaborations around the world. As of 2016 we are listed on the NASDAQ stock exchange and over the last 10 years we have taken several candidate drugs into clinical trials.

When hiring new employees, we look for people who will fit in well with the collaborative, rigorous, and entrepreneurial spirit of our company – a spirit that drives us to develop advanced therapies that address unmet needs in cancer treatment.

REQUIREMENTS

• Advanced (e.g. Masters) degree or equivalent education / degree in life sciences / healthcare;
• 2 – 5 years of experience in clinical development;
• Experience with cross-functional clinical trials, capabilities in supporting operational aspects of clinical trial related activities (planning, executing and reporting) as well as the clinical/scientific aspects;
• Clinical data cleaning experience is preferred;
• Knowledge of GCP (Good Clinical Practice), comprehensive knowledge of clinical trial design and a good understanding of the overall drug development process; Basic knowledge of oncology, hematology, immunology or endocrinology is preferred.

Apply here: https://express.candarine.com/campai...d/012454eee7fb
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