ICON Strategic Solutions Hiring for Senior Clinical Trial Manager at Washington, District Of Columbia Full Time

As a Sr. CTM you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities:

• Clinical project team member: works closely with the Clinical Program Manager and is responsible for leadership, oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables.

• Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations. Primary decision maker on CRO and other vendor selection along with CPM and Director Clinical Outsourcing.

• Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes and maintains strong relationships with investigators, study coordinators, site personnel and other external key stakeholders.

• Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation, accruals, and re‐forecasting, with Clinical Outsourcing, Finance and Project Management.

• Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.

• Works with Patient Recruitment department and is responsible for overall recruitment strategy, enrollment projections, and meeting established targets.

• Oversees and/or participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.

• Leads and participates in internal cross‐functional clinical team meetings; serves as main point of contact for study‐level status updates.

• Presents at management meetings, clinical team meetings and other forums on study progress.

• Works with Study Start‐up and coordinates study start‐up activities including feasibility, investigational product and materials preparation, trial master file set‐ up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.

• Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.

• Participates in SOP development, process mapping, training of junior CTMs and CTAs, and other departmental activities.

• Direct line management and supervision of CTMs and/or CTAs. Responsible for performance reviews and supporting professional development for direct reports.

Experience: 7‐10+ years clinical research experience in a pharmaceutical/ biotech, CRO setting, monitoring experience

• Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials

• Strong leadership, interpersonal, organizational, and multi‐tasking skills

• Excellent attention to detail and problem solving skills

• Ability to work effectively in a team setting

Why 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.

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.

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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.