Responsible for preparing, negotiating, filing, tracking and finalizing the Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA), budgets and Letters of Indemnification (LOI) as well as Amendments to these documents, as needed. Proactively identifies client contract related risks and potential roadblocks. Prepares contract approval timelines with clients and leads efforts to obtain contract approval to meet study deliverables. Develops, revises and maintains clinical contract and clinical vendor related listings and process flow procedures. Processes clinical site and clinical vendor invoices for accounts payable processing. Identifies inconsistencies between the invoice(s) and executed contract(s) and remediates correction with the clinical site(s) and clinical vendor(s). Reviews and approves billing/invoice to required timelines per contract and company policy. Initiates and processes new suppliers per Standard Operating Procedure (SOP) requirements for account setup and maintenance. Maintains communication with clients and management regarding status of all contractual and/or invoicing (A/P) requirements. Provides regular updates to management and/or the projects teams regarding status and efforts to ensure timelines are maintained. Supports vendor audits/assessments per company standard operating procedure (SOP) or upon identified need. Conducts other activities as requirement by direct manager. Participates in corporate initiatives and actions that ensure the continued success of the company.
Required Qualifications :
Education and Experience · Bachelor's Degree with a minimum of 5 years of experience with clinical site and vendor contracts required. · Clinical site contracts, clinical vendor contracts and contract negotiation experience required. · Strong knowledge of hospital reimbursement mechanisms: CMS/Medicare and CPT codes. · Exposure to customer billing/invoicing, accounts receivable and accounts payable processing. · Experience in Australia and New Zealand is not required. Required Skills · Strong computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) and/or eCRF (electronic case report form) required. · Strong written and verbal communication skills and interpersonal relationship skills. · Strong problem-solving and critical thinking skills. · Strict attention to detail. · Ability to work independently and remotely. · Organized and self-directed. · Ability to manage competing priorities in a fast-paced environment. · Working knowledge of GCP/ICH guidelines.