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Legal Staff in San Diego, CA

Intercept Pharmaceuticals, Inc May 06,2016 Mar 13,2016 Location San Diego CA
This job is expired...

In-House

Legal Staff

Corporate - Contract Law

Litigation - Whistleblower - CFTC

5-10 yrs required

Profile

Manager, Clinical Contracts Duties: Prepare, track, review and negotiate clinical contracts and assist to manage the clinical trial agreement (CTA)/site budget processes. Track budget vs. actual on a regular basis, maintain vendor and site purchase order and payment files. Confirm that invoicing from vendors and payments to vendors are carried out in a timely fashion. Confirm budget numbers with budget reports from corporate office. Track site payments and vendor invoicing for clinical trials. This role requires a proactive, self-starter who possesses exceptional multi-tasking, problem solving and communication skills, both oral and written; an energetic person with high integrity who can represent the company with professionalism - interacting with peers and industry colleagues. Must possess excellent organization skills and exercise strong attention to detail. Contracting Duties: Support contractual negotiations with clinical service providers and vendors to ensure appropriate business and legal terms, including reviewing, drafting, summarizing, and revising contract language. Draft and revise a broad range of agreements, including clinical trial agreements (see below), master services agreements, consulting agreements, confidentiality agreements and other commercial agreements. Track and ensure on-time processing of all contracts from initial request through execution in accordance with the project timelines. Responsible for: generating CTA status reports, tracking spreadsheet and/or databases; the overall quality control of CTA/contract tracking; contribute to the constant improvement of the internal site contracting and site payment processes. Provide support to legal affairs and manage clinical contracting activities across multiple projects, as needed. Ensure adequate translation of legal agreements and maintains record of certified translations. Clinical template and clinical trial site budget development Participate in internal and external project team meetings, if required. Accounting Duties: Assist in the development and organization of site payment processes. Enter site-specific budget data to site payment system to ensure accurate and timely accrual of site fees and tracking of payments. Collect the country specific tax forms. Generate and track Purchase Orders for clinical trial site and clinical vendor payments. Other Duties: Support team by reading, researching and routing correspondence; drafting letters and documents; collecting and analyzing information; initiating telecommunications. Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Oversee activities around securing and maintaining Clinical Trial Insurance; track insurance certificates, ensure translations as needed to secure insurance; serve as the primary liaison with the insurance broker. Special project as requested by the Sr. Director, Clinical Contracts, in-house attorneys and other manager; other duties as assigned.

Qualification and Experience

QUALIFICATIONS: Bachelor’s degree; paralegal certificate/degree, a plus 5-10 years of relevant experience, including a significant amount of Clinical trial experience (needed to support CTA, site budget and Clinical Trial Insurance activities) Strong proficiency in Microsoft Excel, Word, PowerPoint, and Outlook Registered Notary Public or willingness to register. Advanced knowledge of the clinical process (Phase I - IV), relevant laws, FDA regulations, corporate terms, conditions and policies governing assigned contracts Advanced knowledge of contract administration and management. A high level of professionalism, organization, and flexibility is key. Strong verbal and written communication skills are essential. Practical, clear; strong attention to detail, and multi-tasking skills Proven planning skills and ability to think creatively in confronting new issues and to think strategically in order to improve current processes. Ability to preempt potential contracting problems and to escalate appropriately with the identification of plausible solutions to remedy the potential problem. Ability to work under pressure, meet deadlines and exercise sound business judgment. Exceptional interpersonal skills and problem solving capabilities. Ability to work effectively across a matrix organization. Ability to work independently and prioritize with minimal daily instruction.

Additional info

Job Tracking ID: 85416-217596

Company info