Description :
Overview : Required to evaluate a drug product or device with knowledge of FDA approval criteria. This requires an understanding of a drug product's mechanism of action and an evaluation of historical preclinical and clinical testing to include chemistry, pharmacology and toxicology. For a device, this requires knowledge of the instructions for use and an evaluation of historical preclinical and clinical testing. Prepare and present a general plan to the VP of Clinical Research and Regulatory Affairs, and to the Associate Director of Research Program Management. The general plan will include the results of a gap analysis. Create a detailed timeline and budget to management and will assume responsibility for implementation of the plan, which requires negotiation and approval of contracts to perform the work necessary to acquire FDA approval, or fulfill an FDA phase 4 requirement in accordance with FDA guidelines and the Federal Code of Regulations. Assure all contracts are performed according to the specified expectations and will be responsible for approval and coding of invoices generated from the work of the plan. Oversee the evaluation of drug products or devices in accordance with their level of experience and education, or, by way of example, may be assigned pieces of a more complex Research Program for which ultimate responsibility for the entire plan lies with a person with a higher level of experience, knowledge, training, and education. Responsibilities : Negotiate, approve, and track legal agreements between R&D, Legal, and investigative studies/vendors. This will include confidentiality agreements, clinical trial agreements, and agreements with laboratories for preclinical studies. It will also include management of consulting agreements to ensure the agreements are completed in a timely fashion, and updating the agreements as required. The Project Manager, Research & Development will be the first point of contact for vendors in terms of negotiation of business terms, oversight of contract performance, and assessment of the propriety of invoices both in terms of technical evaluation of work performed and consistency of the invoice with contractual terms. Resolve contract performance issue and budget discrepancies and payment disputes for those contracts they manage. Oversee limited scope preclinical studies that require further education and training in toxicology studies required for pharmaceutical submissions. Responsible for the development and management of research program plans, including timelines and costs. Utilize Microsoft Project to ensure the successful maintenance of individual timelines and budgets. Review and approve invoices related to the timelines they are actively managing to ensure that billing is appropriate and budgeted. Revise budgets and timelines they are responsible for, as needed, to ensure the R&D quarterly and annual budget allocation is maintained. Amend agreements, as needed, for changes in the scope of work, and revise the budgets and timelines to reflect the changes in scope. Work closely with Finance to communicate changes in timing, or costs, and review their spreadsheets on an ongoing basis to keep the R&D budget up to date. Track the work of completed agreements to monitor work, costs, and timing and also be responsible for the approval of any amendments and cost changes to agreements, as needed. Team leader for departmental teams, coordinating communications, and identifying issues that may delay projects and recommending appropriate action to be taken. Responsible for minutes that serve as historical record of events and commitments, as well as tracking of action items. Must be knowledgeable and sensitive to Legal issues in the dissemination of the minutes. Will serve as a liaison with the Clinical group for meeting deadlines and maintaining budgets, per the research programs they manage. This responsibility will require further training in project and team management. Review of data reports, data management plans, clinical study reports, clinical protocols, preclinical protocols, validation reports and other work related reports that are associated with the research program plans for which this individual is responsible. Report discrepancies or alert supervisor to problems in a timely fashion so that problems are resolved with minimum disruption to project timelines and to ensure the approval of reports. Qualifications : BA/BS degree (Health care related, or finance) with a minimum of 3-5 years clinical research experience; business and finance (Master's level classes or degrees are desirable). A BA/BS degree in another field may be considered based on the person's more extensive work experience with superior performance. Additionally, a Master's Degree in a relevant area may be considered in lieu of work experience. Familiarity with the IND to NDA application process. Familiarity wit ICH Guidelines, FDA Guidances, and the Code of Federal Regulations. Experience with TrialWorks or similar clinical trial and document tracker. Knowledge of finance and budget terminology. Knowledge of GCP (Good Clinical Practice) and pharmaceutical record management. Strong oral and written communication skills. Detail-oriented. Excellent organizational/time management skills. Ability to multi-task. PC proficiency to include MS Project, Word, Excel, PowerPoint and email systems (MS Outlook). AA/EEO Employer