Clinical Contract Administrator
il y a 1 semaine
**Title**: Clinical Contract Administrator **Company**: Ipsen Pharma (SAS) This is a position within the Global Clinical Development Operations (CDO) function supporting the R&D Clinical Trial Excellence (CTE) & Services team to manage and facilitate the management of agreements with healthcare professionals (HCPs) and organisations (HCOs) as well as agreements with patients experts and associations. This role involves working closely in collaboration with internal key stakeholders for the contracting process in particular the Business Ethics and Compliance department in compliance with applicable Ipsen policies and Standard Operating Procedures (SOPs). We are looking for an individual based in Boulogne(France) with a legal or paralegal background preferably and experience with reviews of HCP/HCO and patient agreements. This role will suit individuals who have had more than 3 years’ experience in a pharmaceutical or CRO environment. Main responsibilities and tasks Contracting process The Clinical Contract Administrator works closely with the Clinical Operations project teams, Patient Centricity team, R&D Service Providers, clinical sites and other R&D functional leaders across Clinical Operations, Business Ethics & Compliance, Procurement, Legal, Finance, to ensure appropriate contracts are in place for each of the R&D clinical trials or assets. Main objectives, under supervision: - Generate, draft, negotiate, execute & archive HCP/HCO agreements and patients contracts. - Establish and maintain relationships with the HCPs/HCOS/ Patient Experts and Associations by serving as a single point of contact for contractual matters. - Provide contract-related issue resolution, both internally and externally. - Develop and maintain a contract playbook outlining the process, the different country requirements and timelines, the core stakeholders, the relevant databases and access requirements, all necessary templates and any other relevant information. - Monitor and complete contract close-out, extension or renewal, as appropriate and archiving in the Ipsen contracting tool. The Clinical Contract Administrator is responsible for the overall coordination and management of the contract flow for the contracts in such a manner that it is compliant with legal and compliance guidelines, is delivered in the required quality and within the agreed timelines. The Contract Administrator participates in the low risk resolution of contract-related issues as they arise and escalates to R&D legal any potential high-risk dispute. Operations Must ensure timely contracting ahead of the event. Must work with event organizer to determine parameters of contracts (number of hours, accommodation, travel, expenses, etc) and prepare first draft of contract, using Ipsen templates. Must drive legal review of contracts when applicable Must drive local compliance review of contracts in collaboration with Business Ethics & Compliance Must manage all communication with the HCPs/HCOs/Patients around contracting Must ensure timely reconciliation of expenses and honoraria, via K2 and the invoicing process. Must prepare regular reports for Transparency purposes. General Keeps up to date on emerging clinical trial related contractual management trends in the pharmaceutical industry including country specific requirements Supports training efforts related to clinical contracts management Supports the continuous improvement of standard templates and processes for clinical contracts Ensures smooth collaboration and regular interactions with all the internal stakeholders including Global Ethics and Compliance and Legal Escalates contract related delays / issues to the relevant R&D leadership for transparency and issue resolution needs Is ready to provide back up / support to the other R&D Clinical Contract Leads when requested Experience / Qualifications/Competencies Graduate law degree or > 3 years relevant experience in clinical trial contract reviews and extensive understanding of the legal aspects/requirements of clinical contract standard clauses: - Minimum of 3 years’ work experience reviewing HCP/HCO agreements and patients contracts across international locations - Languages = Fluent in English. Other languages a distinct advantage but not required Soft skills: - Strong attention to detail; Strong organizational skills - Self-motivated team-player with excellent interpersonal and communication skills, while able to work independently - Excellent written/verbal communication and negotiation skills - Strong business acumen, curiosity and willingness to continuously learn and work beyond comfort zone (out of the box thinking without compromising compliance and regulatory requirements) - Ability to meet multiple contract / tasks demands at one time whilst remaining responsive to internal clients’ requests - Strong work ethic, comfortable working in a fast-paced environment with cross-functional teams - Assertive and
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