Regulatory Specialist II

Site Contracts Specialist

Location:  Lyon, France

ICON are currently looking for a Site Contracts Specialist to join our Real World Evidence team in our Lyon office.   Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. 

Combining the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), within ICON Commercialisation and Outcomes, and with access to more combined COA experience than all other CROs and consultancies, we can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business. 

ICON is adding a Site Contract Specialist to our Regulatory Affairs and Contracts team! The Site Contract Specialist is responsible for the development, dissemination, negotiation, and finalization of non-interventional studies and clinical trials agreements and related documents in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPs. This position requires minimal supervision for assigned responsibilities.

Responsibilities/Accountabilities:

• Responsible for preparing, negotiating and monitoring compliance with, new and amended contracts for assigned sites/countries/projects. 
• Responsible for liaising with other departments on requirements for confidentiality and clinical trial agreements (and related documents) between customers (and/or ICON) and investigative sites necessary for the conduct of projects.
• Responsible for providing advice regarding contractual expectations and requirements to investigative sites and internal and external customers.
• Responsible for updating and maintaining contracts information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing.
• Responsible for compiling, analyzing and summarizing legal and business positions of parties during the negotiation of contracts according to Sponsor/project specifications.
• Responsible for examining contracts and related documents to ensure completeness and accuracy, as well as conformance to applicable laws, rules, precedents, company, customer and third party requirements in collaboration with internal and external experts.
• Other duties and responsibilities as assigned.

Education/Experience: 

• Educated with a Law background or equivalent combination of clinical research contract negotiation work experience and education.
• Prior relevant clinical research experience in biotechnology, pharmaceutical, CRO or other health care setting.
• Experience in Clinical Trial Agreements preparation and negotiation on global projects

Knowledge/Skills/Attributes:

• Strong knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP...) and local requirements. 
• Strong written and verbal communication skills.
• Proficiency with computer/software systems.
• Good listening, conflict management and negotiation skills. 
• Strong organizational, time management, interpersonal, listening, conflict management and negotiation skills. 
• Ability to prioritize and coordinate multiple tasks and producing quality results in a timely manner with minimal supervision. Ability to proactively identify issues and address/escalate as appropriate. 
• Ability to work both independently and in a team environment. 
• Ability to exert effective influence upon investigative sites and customers and advanced ability to effectively communicate business and legal rationale for contractual provisions and positions. 
• Moderate to advanced ability to efficiently facilitate resolution of contentious contract provisions, as well as efficiently and effectively drive investigational sites and customers to contract resolution. 
• For non-native English speakers: possess excellent skills in written and spoken English (for international projects).

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.

#LI-SG2