This position is responsible for supporting the processing, negotiation, and execution of clinical contracts and activities, including, but not limited to, purchase orders and site payments, and any associates' duties as assigned. The position supports the Clinical departments (Clinical Operations, Clinical Development, and Medical Affairs) and Regulatory Affairs as requested. This is a contract position - 6 months.
\n What you'll do:Assist in the preparation and maintenance of Clinical Study Agreements and Confidentiality Agreements.Coordinates the review and setup of legal contracts, leases, purchase orders and other agreements for company communicating attorney feedback to internal stakeholders, as needed.Maintains Contracts database along with physical customer contract files and subcontractor agreements.Monitors contract status and communicates to internal stakeholders about contract renewals, execution of rate increases, discounts related to revenue milestones and other contractual obligations.Coordinates the review of RFP/Bid contract documents by company attorney and internal stakeholders to identify possible issues related to language and/or commercial terms.Manages approval, execution and distribution of contracts, amendments and/or extensions of contracts.Assist with processing invoices from vendors Initiate request for investigator, site and vendor payments.Acts as liaison between company, subcontractors and any/all interested parties to contractual agreements with AdverumCreate and maintain relationships with suppliers and serve as the singular point of contact for matters concerning contracts.Maintain records for correspondence and documentation in relation to established contracts and those in progress.Communicate and present information to stakeholders about all contract-related matters.Monitor contracts and move forward with close-out, extension or renewal according to what's best for the company.Provide support in project-specific tasks and the overall management of clinical trials to the Clinical Operations Department.Assist in the coordination and organization of study management team meetings, sponsor and site, and vendor teleconferences, including writing and distributing meeting minutes and agendas.Assist with the planning and logistics of formal meetings including investigator meetings. Help to develop and write SOPs for the Clinical Operations DepartmentOrder and maintain ancillary clinical study supplies required for conduct of clinical trials, including copying, printing study documents, reference binders, and arrange shipping, tracking, accordingly.Prepare reports and documentation on the contract performance and run them by the senior contract manager (if any) Additional Responsibilities for a Sr CM
The Sr CM may assist with approvals of costs above study approved FMV.Assisting in the review/drafting of Clinical SOPs, as requiredOversees, drafts, and/or reviews contract-related processes or SOPs to ensure they align with regulations and best practices for Adverum.Provides direct oversight to CM (I/II) on daily activities and escalations.Acts as a "back-up" if Director is out of office.Other duties as assigned. About you: Bachelor's and/or equivalent experience degree required. Preference in a health care or scientific discipline, such as bachelor's finance, law, business administration, or a similar discipline.Prior experience working as a contract manager or a related job role.Contract drafting and negotiation skills.Accuracy and high attention to detail.Experience within clinical research or related experience in a pharmaceutical, biotechnology, CRO, and/or healthcare setting.Strong attention to detail and excellent organizational skills. Strong interpersonal skills and communication skills (both written and oral), and able to work effectively in a team/matrix environment. Excellent verbal and written communication and presentation skills are required. Experience using Office 365 (Word, Excel, PowerPoint) applications and SharePointExperience with IXRS and EDC systems is a plus. Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures. Ability to develop tools and processes that increase measured efficiencies of the project. Experience in gene therapy and/or rare disease indications preferred.
\n$50 - $70 an hour
Hourly depends on experience
\nAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum's core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control. At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation