Senior Associate Study Manager

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.Senior Associate Study Manager

Work with the clinical trial management staff to support the execution and monitoring of clinical studies and trial deliverables.

Participate in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans.

Contribute to and support with the preparation, writing and review of study related documents including but not limited to, clinical protocols, consent forms, study guides, monitoring plans, e(CRF)s, subject information sheets, clinical study report, regulatory submissions and publications.

Quality Check study protocols and ICFs

Coordinate the activities associated with site start-up and overall trial management

Assist in identification and evaluation of clinical trial investigators and Phase 1 clinical research units.

Author monitoring plan, IPD list, IPIM

Contribute to the study level forecast of IP and support the creation of DSP and JCP

Provide input into the development of CRFs and SAP

Contribute to, or coordinate preparation and conduct of site initiations, monitors workshops (as applicable) and investigator meetings (as applicable)

Assists in preparing and managing Study Budgets and timelines

Coordinate study level investigational product arrangements and study start-up and management activities.

Serve as one of the first points of contact within Early Development for study-related issues

Support vendor relationships

Perform protocol-related site management activities

Assists for ensuring all site and study team members are trained on the conduct of the study and they understand the study timelines and deliverables. Coordinate activities as needed between study team members.

Monitor the execution of the clinical study deliverables against the specified timelines, deliverables, and budget

Lead CST Meetings

Prepare and communicate regular updates to study team.

Contribute to ongoing continuous improvement

Management of Site Activation Process

Trial Master File (TMF) Management

Maintain eClinical

Vendor management (identification, selection, vendor set-up, meeting management, sample/data tracking and approval of invoices)

Line Listing Review Support

IB and CSR Administrative Activities Support (e.g., Facilitating meetings as appropriate, running reports for Med. Writers, CI signature facilitating)

DBL Activities

What do you need to have?Knowledge

Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), FDA regulations and guidelines, and applicable international regulations and guidelines

Experience in interactions with outside vendors, e.g., CROs and contract labs

Experience with development of prospective site –selection criteria

Understanding drug development process and procedures

Good organization, planning & communication skills

Project planning experience including oversight of study deliverables, budgets, and timelines

Ability to use scientific and clinical knowledge to conceptualize study designs

Experience anticipating and resolving problems

Experience writing and presenting clearly on scientific and clinical issues

Experience collaborating and leading cross-functional teams (team/matrix environment)

BS Degree or RN with relevant clinical trial experience

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.