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Investigator Contracts Lead I- FSP

2 months ago

Southeast Fairbanks, United States Parexel Full time

Remote position- any Location US or Canada.

Job Summary:

Investigator Contracts Lead I (ICL I) is responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also includes managing the Per-Subject Cost (PSC) process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO) and collaborating with other lines to plan site contracting timelines though start up.

Key Accountabilities:

Contracting deliverables

Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelinesFollow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trialsWork with partners to develop and oversee the global site budget processWork with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parametersLead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studiesPartner with Legal and other divisions to manage escalations in the site budgeting and contracting spacePartner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting spaceApplies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable disciplineCollaborationLead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interfaceCollaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirementsInteracts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teamsContributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectivesCompliance with Parexel standardsComplies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirementsSkills:Balance of general business, compliance, finance, legal, and drug development experiencePrecise communications and presentation skillsAbility to plan, identify and mitigate risks to site contacting timelinesAbility to lead by influence rather than positional power to accomplish critical deliverablesSuccess in working in a highly matrix based organizationFluency in written and spoken English is requiredKnowledge and Experience:3+ years experience with clinical study budgets and contracting negotiation principles, practices, processes, and activitiesKnowledge of the principles, concepts and theories in applicable business disciplineExperience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferredEducation:Bachelor's Degree or equivalent and 5+ years of experience in clinical development operationsJuris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outs
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