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.
As Principal Clinical Research Manager you will report directly to the Head of the North America Shared Service Center whom has a primary responsibility of Clinical Trial Management oversight of Phase IV trials (i.e., marketed products), Investigator Sponsored Studies, Cooperative Research group studies and Early Access Programs within the North America region.
The Principal Clinical Research Manager (PCRM) is responsible and 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 oversight/review of study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams.
The Principal Clinical Research Manager is accountable for the oversight of Investigator Sponsored Studies, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report.
The Principal Clinical Research Manager contributes to the strategic, value-added perspectives or advisory services that are important to decision, collaborating, using best practices and knowledge of internal and external business practices to improve processes, standards, and services.
Who you are:
- Bachelor’s degree with 8 plus years of experience, master’s degree with 3 plus years of experience, or PhD in a Medical, Life Sciences or related field required
- At least 7 years of experience in clinical research in a CRO, pharma or biotech company strongly preferred
- Experience in clinical trial planning and conduct with a thorough knowledge of ICH GCP and applicable local regulations
- Demonstrated good interpersonal skills, good written and verbal communication skills, and good presentation skills
- Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
- Analytical skills, quick perception and good judgment
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.