Site Contracts Specialist II / Sr

Site Contracts Specialist

Location:  Spain or France in an office or homebased

Mapi is the leading patient-centered research company serving academia, life science researchers, and the pharmaceutical industry. Our commitment to patients is reflected through our wide range of services, including Real World Evidence, HEOR, Linguistic Validation, Global Market Access, and our Mapi Research Trust.  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,  Mapi 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.

Mapi is adding a Site Contract Specialist to our Regulatory Affairs and Contracts team based in Europe working on sometimes global contracts. The Site Contract Specialist II 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.

Your Responsibilities and 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 Mapi) 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.
• Experience in Clinical Trial Agreements preparation and negotiation on global projects

You will have:

• Education to degree level in a relevant field.
• Prior experience in a clinical research environment eg biotechnology, pharmaceutical, CRO or other health care setting.
• Strong knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP...) and local requirements in European markets.
• 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 effectively drive investigational sites and customers to contract resolution.
• Excellent written and spoken English given the international projects.
• Proficiency with computer/software systems.
• 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.

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.