.The Site Budget and Contract Lead (SBCL) leads the development of investigator budget and contract proposals.
The SBCL acts as the main point of contact for budget and contract negotiations for investigator sites across North America, EU and other countries, as applicable, and Sponsors.
The SBCL will be responsible for all project activities related to contracts/budgets and will interact with clients as needed.
Frequent collaboration with internal and external teams is expected.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).You are comfortable working under time pressure and tight timelines.More specifically, the Site Budget and Contract Lead must:Develop and maintain positive and productive relationships with clinical research sites and Sponsors.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.Develop the project-specific Clinical Trial Agreement (CTA) template for studies, customized per country-specific and sponsor requirements.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 amendments during 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).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 using an intermediary party (i.E., contractor, sub-CRO or CRA).Provide oversight to contractors and Sub-CROs, as well as Innovaderm SBCL across multiple countries on contracting activities, as required.Act as functional lead for the contract management piece in global studies as required, acting as the main POC of the sponsor regarding contract management matters.Make all efforts to ensure total study budget is respected and within scope across all sites.
Escalate to sponsor for out-of-scope budget requests, as needed.For employees located in Europe, aid in communicating 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