Study Manager I
About the role
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Location: San Antonio, TX
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 organisation.
With our patients at the center 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 Role:
The Study Manager must be able to objectively assess and apply project management knowledge to ensure that the project is completed in accordance with the scope, quality, timelines and cost of the contract.
* Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
* As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
* Travel (approximately 5%) domestic and/or international.
* Perform duties under general supervision of the Department Manager, the Director, Clinical Operation, Medical Director and PI and be responsible for all aspects of the clinical study for the life of the project.
* Work with cross-functional sections/teams to deliver clinical study projects under the constraints of study scheduling and resources.
* Ensure adequate staffing and training of staff working on assigned projects.
* Act as the primary liaison between the project team and the client.
* Ensure that all outside vendor contracts are set up and deliverables are being meet in accordance to the agreed upon work order.
* Obtain and review clinical statement of work (SOW) and/or study work order (SWO) to determine what services are required for each clinical trial protocol.
* Initiate and participate in the early planning phases of clinical study by providing guidance on deliverables and outsource options (i.e. assist in preparation of study proposal timelines, scheduling and other study requirements as appropriate); including but not limited to study source documents, procedural timelines and lab set up.
* Work closely with clinical research coordinator to ensure adequate internal resources and resolution of any clinical study work flow issues for assigned clinical studies.
* Prepare and maintain project management plan for assigned clinical studies.
* Act as liaison and point of contact for all clinical study sponsors and vendors for related services.
* Attend sponsor meetings and required conference calls to ensure effective communication flow between external customers and staff.
* Present at Clinical Tracking Meetings.
* Lead and/or participate in all IDS study related meetings to include (clinical tracking, screen team and mock runs).
* Initiate Team Meetings as required.
* Track and monitor all clinical study change requests; providing information to all appropriate internal study team members.
* Work with IDS clinical studies unit and external vendors to discuss deliverables and timelines and communicate timelines to sponsor.
* To undertake other reasonably related duties as may be assigned from time to time.
To be successful in the role, you will have:
Education and Experience Requirements
Bachelor's degree or equivalent
2 years of clinical research experience in leading and directing clinical trials
In lieu of a Bachelor's degree or equivalent, a minimum of 5 years of clinical research experience in leading and directing clinical trials
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 through the form below.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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