Ref #: 28715

Employment type: Permanent - Full-Time

Location: Spain

Posted: 27-May-2021

Description

The Role:
The Global Study Associate Manager (GSAM) will lead and coordinate activities that ensure quality, consistency, and integration of global study progress. You will work with and lead cross-functionality, with internal and external partners, on global studies across different phases of drug development and different therapy areas.
Responsibilities:
Monitor study conduct and progress, proactively identifying to and resolving with the Global Study Leader, issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives
Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives
Lead the preparation of study documents as delegated by Global Study Leader ( e.g. Informed Consent Form, Clinical Study Agreement, Patient Participation Card etc)
Support the study delivery team and Clinical Advice and Assurance (CA&A) in the development of and implementation of audits and regulatory inspections
Establish and maintain interactions with key stakeholders including the facilitation of communications with MCs, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities
Contribute to protocol development and the development of other Operations documents as appropriate as well as any updates/amendments to those documents
Provide input and review data management deliverables (e.g. eCRF specification, Data Validation Specification, Data Management Plan)
Contribute to review of new/amended/unique project Clinical Information Standards (CIS) Standards Repository Components
Ensure timely entry and/or update appropriate information into company's tracking and communication tools (e.g. IMPACT, ISSIS and Clinical Partners Portal)
Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers as appropriate
Contribute to the planning and conduct of internal and external meetings (e.g. Investigator/Monitors meeting)
Contribute to steering committees, submission assembly teams, regulatory defence teams, and Advisory Boards as necessary

To be successful on this role, you will have:
Experience working on clinical studies as a Project Coordinator/Associate/Specialist Global CTA or InHouse/Remote CRA across different phases of drug development
Excellent knowledge of spoken and written English
Vendor management experience
University degree in science preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields
Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to Study delivery operational activities

#pmjob #ctajob

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.