SMA II - Germany

Site Management Associate II

Location:  Amsterdam, Netherlands

ICO invites you to learn more about our Site Management Associate II opportunity in Phases III-IV clinical trial studies.  We are seeking to add an additional SMA to our team office based in Cologne, Germany.  We can consider applications for SMA I or II whereby you already have a minimum of 1 year of onsite monitoring experience as a CRA.  We are keen to hear from people with a desire to work on study teams that are often virtual, multi-cultural, and multi-disciplinary. 

The Site Management Associate I / II  is responsible for managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations.  The responsibilities of this position include, but are not limited to:

• Identifying, training/initiating and closing out study sites.
• Negotiating site agreements
• Essential document collection
• Country specific ICF adaptation to local regulations/requirements
• Performing local, central Ethics Committee submissions and Competent Authority submissions
• Conducting remote site monitoring visits and/or targeted on-site visits as needed.
• Conducting remote site management activities.
• Managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained. 
• Travel  up to 25% of your time.

To be considered for the position you will have a Bachelor’s degree in the life sciences.  For more experienced candidates you will have expertise with regulatory guidelines and clinical terminology, and demonstrable site management experience that will ensure your success on our team.  We would also welcome some prior Study Start Up experience ie study feasibility, site identification, ethics committee and regulatory authority submissions, contract negotiations, site activation.  You will need to have fluent written and spoken English and German language skills.  Additionally it would be an advantage to have fluency in French language also.  This would be a great opportunity for someone with the skills and background like an inhouse CRA / remote monitoring CRA.

ICON Clinical Research has a strong reputation in our approaches to clinical development.   We apply scientific and operational excellence across all phases of clinical trial outsourcing services for our clients.   We work with top pharmaceutical organizations on emerging therapeutic areas including Oncology, Internal Medicine and Immunology, Infectious Diseases and Vaccines, CNS, Cardiovascular, and Pain. Additionally, we use cutting-edge technology to ensure better outcomes.

We support our Site Management Associates with manageable workloads and a good benefits package that includes a comprehensive health plan, retirement plans, competitive pay, vacation; bonuses based on performance and great career path.  Additionally, we use cutting-edge technology to ensure better outcomes.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.  

Next Steps:

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.