Senior,Site Budget and Contract Specialist Indero; formerly Innovaderm trabajo Madrid,Andalucia oferta de empleo Servicios Médicos

Puesto: Senior, Site Budget and Contract Specialist Indero (formerly Innovaderm)
About the job

The Senior Site Budget and Contract Specialist (Sr SBCS) leads the development of investigator budget and contract proposals. The Sr SBCS acts as the main point of contact for budget and contract negotiations for investigator sites across North America, EU and other countries, as applicable. The Sr SBCS will be responsible for all project activities related to contracts/budgets and will interact with clients, as needed.

Frequent collaboration with internal teams is expected. Mentoring of more SBCS and other team members in the contracts/budgets related field.

This role will be perfect for you if

You can easily achieve consensus while maintaining positive working relationships with external partners

Your team can count on you to get things done

You have an ease to work with numbers (standardized budgets)

Responsibilities

Develop and maintain positive and productive relationships with clinical research sites and clients

Develop the draft clinical budgets for new studies

Develop and maintain the country-specific, sponsor approved, minimum and maximum budget grid for negotiation with sites (more complex studies)

Obtain the approved Clinical Trial Agreement (CTA) template to be used for the study from Legal Affairs

Develop the project-specific Clinical Trial Agreement (CTA) template for studies, customized per country-specific requirements on a global scale

Facilitate the negotiation and signature of the site budgets/contracts with investigators, in collaboration with Legal Affairs, and when appropriate with Sponsors. Adapt processes per country-specific requirements.

Manage contract/budget negotiations in countries outside of main region (EU-NA), if possible

Manage contract/budget amendments during the course of the trial

Update appropriate tracking systems to facilitate site payments

Regularly attend internal and client project team meetings, as necessary

Collaborate with internal teams as needed (i.e., Project Management, Regulatory Affairs, Legal Affairs, Finance, CTMS team, etc.)

Strategize to ensure deliverables for fully executed contracts are made on time, according to study timelines

Review and provide support to Regulatory Affairs on informed consent form (master template) to ensure subject compensation text is aligned with approved study budget

Depending on location and language of study sites, facilitate site negotiations and communications through the use of an intermediary party (i.e., sub-CRO or CRA)

Provide oversight to Sub-CROs on contracting activities, as required

Make all efforts to ensure total study budget is respected and within scope, across all sites. Escalates to sponsor for out-of-scope budget requests, as needed

For employees located outside of North America, provide assistance, as needed, to communicate with sites in local language, if possible

Maintain adequate training and compliance with internal processes and SOPs

Participate in internal departmental projects initiated by the site selection and contracting group

Participate in internal departmental projects initiated by other groups to provide insight on site budget and contracting activities as needed

Act as subject matter expert on budget and contract negotiations guiding project teams as needed

Support the Manager, Site Selection and Contracting to ensure knowledge of the goals, scope and requirements of the internal and external projects and to ensure high quality results are delivered

Mentor and assist in onboarding of new team members as well as provide trainings to the team on the specific processes related to contracts and budgets

Requirements Education

Bachelor’s degree in a field relevant to clinical research or equivalent experience.

Experience

Minimum of 5 years’ experience in site budget/contract negotiation…

Senior, Site Budget and Contract Specialist Indero; formerly Innovaderm