A career with EMD Serono is an ongoing journey of discovery: our 52,000 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 a business of Merck KGaA, Darmstadt, Germany.
Clinical Trial Management is responsible for the strategic and tactical operational delivery and execution of R&D sponsored programs for all corporate sponsored programs for Phase I - Phase IV. The Global Clinical Trial Lead is responsible and accountable for planning, coordinating, overseeing and conducting complex global clinical trials in one or more therapeutic areas.
The Global Clinical Trial Lead collaborates in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards and services.
The Global Clinical Trial Lead is accountable to drive and monitor protocol related activities throughout the lifecycle of the project(s) ensuring targets are met according to timelines, budget and quality expectations. Leads multiple cross-functional teams and drives oversight of CRO’s and vendor management according to partnership model and as 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, customer and key business drivers to increase effectiveness.
Who You Are
- Bachelor's degree with 1 plus year of experience
- Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) preferred
- Substantial professional experience in clinical research in CRO, Pharmaceutical or Biotechnology Industry with at least 5 years of expertise in clinical trial management including management responsibility strongly preferred
- 4 plus years of technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization (executing the complete range of clinical trial activities, from start up through final trial report) preferred
- Six sigma black belt preferred
- Proven track record of having successfully led one or more multinational trials
- Hands-on experience in data cleaning and analysis
- Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process
Position can be in Billerica, MA, Rockland, MA, or remote if you reside greater than a 50-mile radius from our Billerica and Rockland, MA, location.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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
The Company 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.