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ICON Strategic Solutions · 11 hours ago

Senior Associate Study Manager

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

ICON plc is a world-leading healthcare intelligence and clinical research organization. The Senior Associate Study Manager will support the execution and monitoring of clinical studies, participate in study planning, and manage vendor relationships while ensuring compliance with regulatory standards.

Pharmaceuticals

Responsibilities

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

Qualification

Clinical trial managementRegulatory knowledgeProject managementVendor managementStudy protocol writingCommunication skillsProblem-solving skillsTeam collaboration

Required

Knowledgeable in International Conference on Harmonization (ICH), Good Clinical Practice (GCP), FDA regulations/guidelines, and applicable international regulatory standards

Experienced in interactions with external vendors (e.g., CROs, contract labs)

Skilled in developing prospective site-selection criteria

Well-versed in the drug development process and related procedures

Organized and effective in planning and communication

Proficient in project planning with oversight of study deliverables, budgets, and timelines

Able to apply scientific and clinical knowledge to conceptualize study designs

Adept at anticipating and resolving problems proactively

Clear and concise in writing and presenting on scientific and clinical topics

Collaborative, with a proven ability to lead in team and matrix environments

Educated with a Master's degree, or a Bachelor's/RN and 3+ years of experience, or an Associate's and 6+ years, or a High School diploma and 10+ years in a life sciences or medically related field

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs.

Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.