Administers and negotiates site contracts that support projects withinClinical Operations on a global scale, with moderate oversight from the SSUCountry Manager.Ensures site contractdocumentation is in compliance with sponsor and Company requirements.Identifies project and/or individual sitecontract related problems and works with internal and external team members toprovide and implement solutions.Servesas technical expert across all Site Contracts functions.Trains and mentors junior team members andproactively identify ways to improve internal project operations. Establishesstrong working relationships with customer, internal project teams and sites.Ensureall relevant documents are submitted to the Trial Master File (TMF) as perCompany SOP/Sponsor requirements.
May participate in internal team education or process improvementinitiatives.
- Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
·Maylead (with supervision) multi-country projects including negotiating andpreparing contracts, budgets, and related documents for participation in industry-sponsoredclinical trials.
- Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template.Provide support in submissions for proposed contract and budget for site.
- Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
- Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
- Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
- Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
·Work withContract Managers and team members with the active project management ofongoing contract issues; performs follow-up on all outstanding contract issues.
- Supports in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
·Workswithin the forecasted country/site contracting timelines, ensures they arecomplied with and tracks milestone progress in agreed upon SSU tracking systemin real time.
- Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
- Facilitates the execution of contracts by company signatories.
- Maintains contract templates and site specific files and databases.
- Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products.Maintains and updates training material for site contract team.
- Acts as a communication liaison between site contracts staff and internal and external customers.Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.Prepares correspondence as necessary.
·Monitorsbasic financial aspects of the project and the number of hours/tasks availableper contract; escalates discrepancies in a timely fashion.
·Reviewsand complies with Standard Operating Procedures (SOPs) and Work Instructions(WIs) in a timely manner, keeps training records updated accordingly andensures timesheet compliance.
QUALIFICATION & REQUIREMENTS
- BA/BSdegree in Business Administration, Public Administration, Public Health,related field, or equivalent combination of education and experience.Advanced degree preferred.
- Highlevel of contracts management experience.
- Experiencein a contract research organization or pharmaceutical industry essential.
- Strongknowledge of the clinical development process and legal and contractingparameters.
- Strongcomputer skills in Microsoft Office Suite.
- Customerfocused and ability to manage challenging priorities and to remain flexible andadaptable in stressful situations.
- Excellent understanding of clinical trial process across PhasesII-IV and ICH GCP.
- Good understanding clinical protocols and associated studyspecifications.
- Excellent understanding of clinical trial start-up processes.
- Project management experience in a fast-paced environment.
- Good vendor management skills.
- Excellent written/oral communication, presentation, documentation,interpersonal skills as well as strong team-orientation.
- Strong organizational skills with proven ability to handlemultiple projects excellent communication.
- Quality-driven in all managed activities. Strong negotiatingskills. Strong problem-solving skills.
- Abilityto mentor, lead and motivate more junior staff.
- Demonstratean ability to provide quality feedback and guidance to peers Contribute to atraining and Quality assurance plan within SSU and update SOPs/WI.