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PRAHS Start-Up Specialist in United States

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

We are looking for a Start Up Specialist to be be dedicated to one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend people’s lives in oncology, general medicine and eye care. Working in this way, you will have the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance.

The Study Start Up Specialist is accountable for planning, executing clinical trial application submissions to authorities and management of Clinical trial contracts, in compliance with sponsor processes and regulatory requirements. This position is key to ensure the Start up phase to be conducted within the agreed timelines and with high quality.

Responsibilties include but are not limited to:

  • Facilitate start-up process for clinical trials in close collaboration with other TMO colleagues and external vendor if applicable

  • Plan, execute, manage and track ethics submissions during study start-up in a timely manner

  • Have a full knowledge of requirements and timelines related to the ECs of the sites currently or recently involved in sponsor clinical trials

  • Bring consistency and expertise to the ethics submission process for clinical trials during study start-up

  • Deliver accurate and timely communication to relevant stakeholder (i.e. Country Head, Country DRA or Regional Hub, DSM, RARM, TOMs, Legal and investigators and their staff) and liaise with appropriate

  • Ensure and manage a continuous review and improvement of the ethics submission process by providing feedback on the central activities to the process owners

  • Facilitate meetings to discuss new trends and share best practices with CRA Managers, CRAs and CSMs

  • Perform submission and follow-up regarding additional submissions to the Ethics Committee (i.e. protocol and ICF amendments, INs and additional documents) after the study start-up and follow-up on approvals if applicable

  • Collection, submissions, entry, tracking and follow-up of documents

  • Prepare and adapt local informed consent (general country local version and site specific versions)

  • A degree or equivalent in a scientific or health care discipline

  • Understand and apply medical and business knowledge to clinical trial execution

  • At least 5-6 years experience in clinical research or having demonstrated adequate level of proficiency within the CRA competency profile

  • Solid understanding of clinical trial design, trial execution and operations

  • Knowledge of international standards (GCP), international (FDA, EMEA) and local regulations

  • Expertise in communication, managing multiple priorities and computer literacy

  • Excellent interpersonal skills, proven people management skills with demonstrated good expertise in team work.

  • Proven good negotiation skills

  • Fluent in English and Danish is required.

  • Right to live and work in Denmark. ICON does not sponsor work visa for this role.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

ID: 2021-79980

External Company Name: Pharmaceutical Research Associates, Inc

External Company URL: http://prahs.com/

Post End Date: 9/15/2021