CenterWatch

Keep the discussion going--join our JobWatch Group on LinkedIn!

Sign In
 [New User? Sign Up]
Mobile Version

Principal Clinical Research Manager

EMD Serono


Location:
Rockland, Massachusetts
Date:
06/13/2017
2017-06-132017-07-13
Categories:
  • Healthcare
  • Clinical Operations
EMD Serono
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Who We Are:

A career with EMD Serono is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

EMD Serono is the North American biopharma brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the brand has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas.

Your role:

Regional Clinical Operations is responsible for the strategic and tactical operational delivery and execution of our late phase clinical trials across our product portfolio.

The Principal Clinical Research Manager (PCRM) is responsible and accountable for planning, coordinating, overseeing, and conducting complex local/regional clinical trials in one or more therapeutic areas.  The Principal Clinical Research Manager contributes strategic, value-added perspectives or advisory services that are important to decision, collaborating, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.  The Principal Clinical Research Manager is accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations. Leads cross-functional teams and drives oversight of CRO’s and vendor management.  Has in-depth business knowledge and strategic understanding of how cross-functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers and key business drivers to increase effectiveness. The Principal Clinical Research Manager has significant impact on a range of important customer, operational, project or service activities within own team and other related teams that affect team performance and the way people work.

You will be accountable for day to day activities of all aspects for the management of local and/or regional company-sponsored studies, as well as Global Phase IV studies, including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams. You will manage independent consultants including CRO's, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment. You will develop and monitor study budget and timelines and monitor work to ensure quality.

Who you are:

  • Medical or Life Sciences degree or equivalent qualification
  • Requires substantial professional experience (at least 7 years) in clinical research in CRO, Pharmaceutical or Biotechnology Industry with the majority of expertise in trial management
  • Proven experience in all aspects of clinical trial management
  • Proven track record of having successfully led one or more clinical trials

What we offer:

With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2emd.com

EMD Serono is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.