PRAHS Hiring for Senior Project Associate at United States Full Time

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.

The key operational responsibilities for Project Associate:

1. Prepare and/or coordinate the preparation of project / study materials for internal and / or with vendors such as:

• Consistent and collaborative communication to internal (CSM, IMM, GCO – SLM, CLM, CRA, etc.) and external partners (CRO, Laboratory, etc.)

• Creation and sending communications materials to countries and/or study sites (e.g. Newsletters, study document updates, )

• Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return. (i.e. CDAs, 1572s, CVs, IRB-IEC documents such as approvals, HA and EC submissions, renewals, membership list and other study agreements)

• Submission of IRB – IEC documents for approval

• Set-up and maintenance of study specific internet based forums, such as study websites IRB – IEC sites, etc.

• Coordination of communication of project/study status to various levels of management

• Managing and maintaining study information documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits & Medical equipment for sites

• Support the teams with ongoing conduct of studies, at all milestones

1. Organization, maintenance, reconciles and archiving of paper or/and electronic Trial Master Files (eTMF) and assistance with eTMF administrative support activities

2. Participate and support audits, inspections (Regulatory Authorities) and verification of TMF. Ensuring the quality, completeness, availability and quality of the clinical study documents in the Trial Master File to enable final compilation of the documents for regulatory submissions and marketing approval of new medications and medical devices. Participate and support quality checks of the Trial Master File

3. Maintain operational tracking and reporting systems and tools

4. Provide meeting coordination for the global / local clinical and study team members (StM, SLM GCPM, IMM, CLM, LM etc…) in scheduling, agenda, presentations, arrangements, minutes, and action item tracking including global and regional investigator meetings, global/regional monitor training meetings (if applicable) and advisory committee meetings as requested by GCPM/GCL

WHO YOU ARE (qualifications and competencies)

The clinical development study and project coordination activities are accomplished through strong skillset, understanding of clinical development and global operating processes of drug development as well as in-depth knowledge of ICH-GCP and international regulations.

The incumbent must have a 4 year college degree or with equivalent relevant experience. The incumbent must have 3 – 5 years of experience with clinical trials or in the healthcare field, pharmaceutical industry or clinical research / development.

The incumbent must have the ability to manage multiple high level parallel tasks; work unsupervised, have effective computer skills, possess the ability to apply new techniques, have excellent knowledge of all Microsoft Office programs, and strong prioritization skills. The incumbent’s previous experience should demonstrate analytical and problem solving ability. Must display excellent planning and organizational skills, innovativeness, and keen attention to detail and excellent follow The incumbent must have strong interpersonal skills and must be able to manage high level professional relationships with internal and external customers, like international teams, 3rd parties and people in a global environment.

Language skills: Excellent in native language and fluent in English, in both written and oral communication.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.

ICON, including subsidiaries, 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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

ID: 2021-84639

External Company Name: Pharmaceutical Research Associates, Inc

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