Senior Contract Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79gnmb

ppBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. /p h3General Description /h3 pThe Senior Contract Associate is responsible for drafting, negotiating, and finalizing complex Clinical Site Contracts related to clinical trials throughout the lifecycle of the study, and performs timely and accurate data entry into all Clinical Business Operations operating systems, including but not limited to the company Contract Management System (CMS). The Contract Associate is also responsible for meeting deliverables with high quality and within the project timelines. The contracting activity supported by the CBO team is fast-paced, with short deadlines and quick turnaround times therefore Contract Associate must be capable of managing priorities effectively, proactively communicating issues and working in a fast-paced environment. /p h3Essential Functions Of The Job /h3 ul liPrepare, negotiate, and finalize clinical trial agreements, ancillary agreements and amendments of company sponsored studies through direct communication with sites. /li liResponsible for execution of contracts against planned timelines and targets. /li liManage budget grid in the contract. Ensure the cost calculation are consistent with protocol and agreed with site. /li liDemonstrates an understanding of records management requirements for contract documents /li liComplete quality check (QC) of final approved contract and budget documents, and initiates signature process of assigned contracts to the responsible signing parties. /li liEnsure final contracts are delivered to agreed timelines, within Fair Market Value in compliance with relevant legal and regulatory requirements /li liServe as the primary point of contact between CBO and Global Clinical Operations (GCO), Legal, Investigator Sites and external service providers in accordance with the study related activities to meet business needs; /li liCollect and maintain country and site intelligence information for each country and/or site, and prepares country/site specific contract process flows as needed; /li liForecast, set, track and communicate fully executed contract planned dates, and make all efforts to achieve the set planned date,



ensuring the CM and study teams are proactively informed of changes and/or risks to the projected dates; /li liLiaise with CM and BeiGene legal to review and update contract template(s) as needed, including Master Clinical Trial Agreements/Clinical Trial Agreements/Project Agreements or any other Site agreement template(s); /li liLiaise with CM and BeiGene legal to contribute updates to the BeiGene Legal Playbook guidance document as needed; /li liLiaise with Investigator Payment Management (IPM) team to ensure site contracts, including investigator site budgets, are approved and executed in accordance with CBO guidelines and BeiGene policies; /li liEnsure all investigator contracts are reviewed and approved by legal and/or delegate prior to execution, and in accordance with CBO and BeiGene legal guidelines; /li liCommunicate legal and budgetary issues to internal and external parties per department guidelines, as needed; /li liPerform legal translation of contract language for Sites, as needed; /li liMaintain active and regular communication with site personnel and internal BeiGene partners, with regular progress tracking and updates provided throughout the contract lifecycle; /li liPrepare subsequent contract amendments, note to files and other related contract documents, as needed; /li liEscalates contracting issues and/or potential delays to internal and external stakeholders, as necessary; /li liAttend and actively participate in Investigator Site, project related, CBO, and other meetings, as necessary; /li liUpdate and maintain CBO trackers with real-time updates on a regular basis, complete CBO related filing and distribution of contract documents, and maintain Contract Management System (CMS) records, in accordance with CBO and BeiGene policies; /li liProvides a handoff to the project/payment team upon execution of a site’s final contractual documents /li /ul h3Education Required /h3 ul liBachelor's degree with 3 or more years clinical research site contracting and budgeting with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor or /li liup to four (4) years in clinical operations, preferably within the biotechnology, pharmaceutical, and/or CRO industry.



/li /ul h3Computer Skills /h3 ul liMicrosoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Beep/Sharepoint /li /ul h3Other Qualifications /h3 ul liExperience with Clinical Trial Agreements, budgeting and fair market value principles /li liExplain data, facilitate decision-making processes to be data-driven /li liGood knowledge of ICH-GCP, pharmaceutical related regulations and laws; /li liGood understanding of clinical trial contracting process, and relevant clinical operation practices; /li liAwareness and understanding of compliance and regulatory matters in clinical research. /li liProven negotiation, interpersonal and business skills. /li liStrong planning and organizational skills and the ability to work independently and effectively in a dynamic environment with competing priorities. /li liSense of urgency and strong goal orientation; track-record of meeting deadlines and goals. /li liStrong written and verbal communication including written and verbal fluency in English and local language (if not English) and interpersonal skills, including conflict resolution and problem solving. /li liProactive and positive team player. Able to maintain high performance during times of ambiguity and change in the work environment. /li liExperience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable /li liHas knowledge of Intellectual Property issues, Publication issues, Indemnification issues and other standard issues of site contracts within the clinical research area. /li liMust be willing to work in a fast-paced environment with time-sensitive material. /li liDemonstrated ability to work effectively at all levels of an organization. /li /ul pTravel: Yes, 10% /p pSalary Range Italy: 53,300.00 EUR - 66,600.00 EUR /p h3Global Competencies /h3 ul liFosters Teamwork /li liProvides and Solicits Honest and Actionable Feedback /li liSelf-Awareness /li liActs Inclusively /li liDemonstrates Initiative /li liEntrepreneurial Mindset /li liContinuous Learning /li liEmbraces Change /li liResults-Oriented /li liAnalytical Thinking/Data Analysis /li liFinancial Excellence /li liCommunicates with Clarity /li /ul pWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79gnmb