Parexel International Corporation
Site Contract Leader
Parexel International Corporation, King Of Prussia, Pennsylvania, United States, 19406
The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, sitespecific and country Clinical Site Agreements (CSA) and any other agreement that is required for thecompletion of the Site Initiation Visit (SIV).
The Site Contract Leader is also responsible for managingCSA activities and liaising with study specific stakeholders to ensure that the CSA start-up deliverables are met.
Key AccountabilitiesAct as functional Leader on projects and develop study specific CSA strategyDrafting legal language and creating budgets for CSA negotiationsAgree and negotiate study specific CSA templates with the Sponsor and Site as applicableCommunicate CSA strategy, CSA turnaround timelines, tracking requirements andbudget information/updates with key stakeholders.Coordinate interaction betweenParexel study team and Sponsor as applicable to include but not limited to overalltimeline management for CSA delivery.Provide updates about template amendments, process changes, investigator fees, localrequirements etc. to ensure that relevant CSA database is maintained in real timeEarly recognition of areas of potential problems and formulate contingency plansDefine solutions strategy of significant CSA changes requested by the siteParticipate in client and team meetingsIdentify and facilitate CSA training needs as applicableMaintain and assure quality of work generatedPrioritize effectively and respond to urgent requests within team or sponsor leadMaintain a working knowledge of, and ensure compliance with applicable ICH-GCPGuidelines, local regulatory requirements, and Parexel SOPs and study specificproceduresComplete routine administrative tasks in a timely manner (e.g. Timesheets, metrics,travel expense claims)The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, sitespecific and country Clinical Site Agreements (CSA) and any other agreement that is required for thecompletion of the Site Initiation Visit (SIV).Qualifications :Minimum Work Experience* 1-3 Years' experience in site contract negotiation
Skills* Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability* Excellent interpersonal, verbal and written communication skills* Ability to motivate both individuals and a team.* Ability to successfully work in a "virtual" team environment* Must have strong analytical skills with the ability to create or interpret legal language andbudgets* Demonstrate thought leadership and innovation* Maintain grace under pressure while displaying a high level of professionalism* Align internal and external resources to achieve objectives* Attention to detail* Work effectively as part of a team* Comprehend and interpret contract language* Identify problems independently and execute solutions* Quickly comprehend desired end-result, goal or objective and act to accomplish* Demonstrated effective decision-making* Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint* Polished presentation skills
Education* Degree in business, legal or life science or other relevant work experience inContracting, Clinical Operations or in Legal (Paralegal).
Language Skills* Fluent in written and spoken English.
The Site Contract Leader is also responsible for managingCSA activities and liaising with study specific stakeholders to ensure that the CSA start-up deliverables are met.
Key AccountabilitiesAct as functional Leader on projects and develop study specific CSA strategyDrafting legal language and creating budgets for CSA negotiationsAgree and negotiate study specific CSA templates with the Sponsor and Site as applicableCommunicate CSA strategy, CSA turnaround timelines, tracking requirements andbudget information/updates with key stakeholders.Coordinate interaction betweenParexel study team and Sponsor as applicable to include but not limited to overalltimeline management for CSA delivery.Provide updates about template amendments, process changes, investigator fees, localrequirements etc. to ensure that relevant CSA database is maintained in real timeEarly recognition of areas of potential problems and formulate contingency plansDefine solutions strategy of significant CSA changes requested by the siteParticipate in client and team meetingsIdentify and facilitate CSA training needs as applicableMaintain and assure quality of work generatedPrioritize effectively and respond to urgent requests within team or sponsor leadMaintain a working knowledge of, and ensure compliance with applicable ICH-GCPGuidelines, local regulatory requirements, and Parexel SOPs and study specificproceduresComplete routine administrative tasks in a timely manner (e.g. Timesheets, metrics,travel expense claims)The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, sitespecific and country Clinical Site Agreements (CSA) and any other agreement that is required for thecompletion of the Site Initiation Visit (SIV).Qualifications :Minimum Work Experience* 1-3 Years' experience in site contract negotiation
Skills* Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability* Excellent interpersonal, verbal and written communication skills* Ability to motivate both individuals and a team.* Ability to successfully work in a "virtual" team environment* Must have strong analytical skills with the ability to create or interpret legal language andbudgets* Demonstrate thought leadership and innovation* Maintain grace under pressure while displaying a high level of professionalism* Align internal and external resources to achieve objectives* Attention to detail* Work effectively as part of a team* Comprehend and interpret contract language* Identify problems independently and execute solutions* Quickly comprehend desired end-result, goal or objective and act to accomplish* Demonstrated effective decision-making* Solid working proficiency of all MS Office Products specifically, Excel, Word, and PowerPoint* Polished presentation skills
Education* Degree in business, legal or life science or other relevant work experience inContracting, Clinical Operations or in Legal (Paralegal).
Language Skills* Fluent in written and spoken English.