Clinical (Trials) Manager (40 hrs/wk)

Clinical (Trials) Manager (40 hrs/wk) 
Clinical Development, Merus US, Inc.


Oversee and conduct all operational aspects and support scientific aspects of our (global) clinical trials

The team: 
The Clinical Development team is responsible for all of the clinical trials we conduct for our product candidates. Currently we have two product candidates in three ongoing clinical trials; a Phase 2 combination clinical trial in breast cancer patients, a Phase 1/2 clinical trial in patients with gastric, ovarian and endometrial cancer and a Phase 1 clinical trial in patients with acute myelogenous leukemia. In the first quarter of 2018 we plan to start with a new product candidate in a Phase 1, first-in-human clinical trial targeting colorectal cancer.


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;
  • 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.

Your profile: 
We are looking for a Clinical (Trials) Manager with the following knowledge and expertise:

  • 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;
  • 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 preferable.

Our offer: 
We offer a competitive salary and flexible working hours. You will be stationed in the New York/Boston area and may be required to travel to the headquarters in the Netherlands.

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. For more information, please visit www.merus.nl.


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.


Interested? 
For more information about this role, please contact Mr. Jim Ford (Senior Director Clinical Trials) via telephone number +1 (857) 260 8202.

For more information about the application procedure, please contact Merus Recruitment via telephone number +31(0)30 – 253 8800 or by email at vacancies@merus.nl.


Please send in your application by April 10, 2018, at the latest with reference 2017WH12 via the following link: http://bit.ly/Clinical-Manager-US


This vacancy is a full time position.

Published
26-03-2018
Location
Cambridge, MA (U.S.A.)
Educational Level
Master / Post-Graduate / PhD
Salary
Keywords
Sector
Biotechnology
Region
United States
Keywords