Ref #: 28569

Employment type: Permanent - Full-Time

Location: United States - remote

Posted: 13-May-2021

Description

WHO WE ARE:

At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.

All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you

JOB DESCRIPTION:
GSM
The GSM supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSM works cross-functionally with internal and external partners to lead & deliver aspects of the clinical study in accordance with Senior Global Study Leader (Sr. GSL) or Global Study Leader (GSL) delegation, applicable clinical trial regulations (ex. ICH-GCP), Standard Operating Procedures (SOPs), policies & best practices and values & behaviors.

• Perform study management tasks as per agreed delegation/oversight by Sr. GSL/GSL.
• In partnership with internal experts and external service providers, provide oversight (as delegated by the Sr. GSL/GSL) to ensure study delivery of both internally-run and outsourced studies.
• Lead/contribute to the preparation of delegated study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents (e.g. specifications, study specific procedures, etc.)
• Maintain and facilitate interactions with both internal & external functions to ensure efficient study delivery to time, costs and quality objectives.
• Manage the set-up and maintenance of third-party vendors.
• Support the Sr. GSL/GSL with budget management. Initiate contract/budget requests for third-party vendors, facilitate generation of purchase orders, track spend against approved budget and manage the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
• Contribute to the planning and conduct of internal and external meetings.
• Ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
• Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
• Ensure that all study documents within scope of the GSM’s responsibilities are complete and
verified for quality in the Trial Master File (TMF).
• Adhere to SOPs, global process, applicable Quality & Compliance manual documents and international guidelines (e.g. ICH-GCP) to ensure study is inspection ready at all times.
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular process or system within Study Management Early.

#pmjob

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
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.
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.

Following is the list of all posted jobs on Avature with the posting fields - https://docsglobal.avature.net/#Jobs/Id:1235.