PRAHS 2018-50888 in United States
PRA Health Sciences is an award winning CRO.
We are proud to have won Pharma Times 'Clinical Research Company of the Year' in 2018 for the fifth consecutive year. We aren’t winning these awards by chance; PRA is being recognised industry-wide for our dedication to the future of clinical development. Most importantly for you, at PRA we recognise that our success is down to our people.
As a Clinical Research Manager (CRM), you will be dedicated to one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most challenging diseases including Infectious diseases, Vaccines and primary care. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.
The Clinical Research Manager role is accountable for the end to end performance for assigned studies in a country in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster.
Responsibilities include, but are not limited to:
Main Point of Contact for assigned studies and link between Country Operations and clinical trial team.
Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
Knowledge in Project/Site Management
Strong organizational skills with demonstrated success required
Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD
Requires strong understanding of local regulatory environment
Strong scientific and clinical research knowledge is required
Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
Proficiency in written and spoken English and Swedish. The incumbent must be competent and effective in written and verbal communication.
Be willing to travel within other countries in the Nordic-Baltic cluster
Be flexible, problem-solving and positive. Sees possibilities instead of problems
Preferred if candidate has an established network with KOLs and other sites within our TA pipeline
5-6 years of experience in clinical research of which 3 as CRA
Bachelor degree in Science (or comparable)
Advanced degree, (e.g., Master degree, MD, PhD)
External Company Name: Pharmaceutical Research Associates, Inc
External Company URL: http://prahs.com/