Study Start Up Manager Remote
ICON
Full Time
Remote
10.56 - 12.04 GBP Today
Job description
As a Manager of Study Start Up you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
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 Manager, Site Start-Up (SSU) is responsible for Site Start-Up activities and includes coordination, management, and oversight of Site Start-Up for two or more clinical studies.
What you will be doing:
Accountable for site Start-Up for 2 or more clinical studies.- Serves as primary point of contact (POC) and escalation for Site Start-Up on assigned clinical studies.
- Holds Start-Up Kick Off Meeting with Manager, Study Start-Up, European Union (EU), Protocol Lead (PL), Clinical Contracts Manager (CCM), Legal, and other key stakeholders.
- Holds weekly Start-Up meetings with Manager, SSU, EU, PL, CCM, Legal, and other key stakeholders as necessary.
- Forecasts and tracks progress of Site Start-Up, ensuring all sites on assigned clinical trials are greenlit on time per study Start-Up timelines.
- Escalates site issues to appropriate Clinical Study Team members.
- Attends Clinical Study Team Meetings through Start-Up.
- Prepares and updates Start-Up packets for clinical studies.
- Assigns sites to Study Start-Up Specialists, manages Study Start-Up Specialist and Study Start-Up
Assistant workload for assigned studies.
- Ensures Study Start-Up Specialists collect, review, and track essential documents, and review Informed Consent Form (ICFs) in accordance with Client processes and timelines.
- Ensures Study Start-Up Team members are properly trained on site Start-Up activities and kept current on timelines, contract and budget status, and study updates for assigned clinical studies.
You are:
Minimum of 5-8 years of relevant clinical trial experience.- Minimum of 2-4 years clinical trial management or equivalent Start-Up unit management experience.
- Thorough knowledge of clinical Start-Up process and requirements required.
- Thorough knowledge of CFR and ICH/GCP requirements is required.
- Requires effective organizational and time management skills.
- Able to multi-task under limited direction and on own initiative.
- Strong communication and inter-personal skills.
- Ability to coordinate work cross-functionally with diverse teams.
- Highly responsive and proactive, a team player.
- Previous Start-Up unit experience, preferred.
- Experience managing large teams (direct or dotted line reporting), preferred.
- Oncology clinical research experience, preferred.
- Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint
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.
ICON
www.iconplc.com
Dublin, Ireland
Steve Cutler
$500 million to $1 billion (USD)
10000+ Employees
Company - Public
Biotech & Pharmaceuticals
1990
