04 ago
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BeOne Medicines ESP, S.L.U.
|
España
04 ago
BeOne Medicines ESP, S.L.U.
España
ph3General Description /h3pBeOne 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. /ph3Essential Functions of the Job /h3ulliPrepare, negotiate, and finalize clinical trial agreements, ancillary agreements and amendments of company-sponsored studies through direct communication with sites. /liliResponsible for execution of contracts against planned timelines and targets. /liliManage budget grid in the contract. /liliEnsure the cost calculation are consistent with protocol and agreed with site. /liliDemonstrates an understanding of records management requirements for contract documents. /liliComplete quality check (QC) of final approved contract and budget documents, and initiates signature process of assigned contracts to the responsible signing parties. /liliEnsure final contracts are delivered to agreed timelines, within Fair Market Value and in compliance with relevant legal and regulatory requirements. /liliServe as the primary point of contact between CBO and Integral Clinical Operations (GCO), Legal, Investigator Sites and external service providers in accordance with the study related activities to meet business needs. /liliCollect and maintain country and site intelligence information for each country and/or site, and prepares country/site specific contract process flows as needed. /liliForecast, 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. /liliLiaise with CM and BeOne Medicines 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). /liliLiaise with CM and BeOne Medicines legal to contribute updates to the BeOne Medicines Legal Playbook guidance document as needed.
/liliLiaise with Clinical Site Budgets and Payment team to ensure site contracts, including investigator site budgets, are approved and executed in accordance with CBO guidelines and BeOne Medicines policies. /liliEnsure all investigator contracts are reviewed and approved by legal and/or delegate prior to execution, and in accordance with CBO and BeOne Medicines legal guidelines. /liliCommunicate legal and budgetary issues to internal and external parties per department guidelines, as needed. /liliPerform legal translation of contract language for Sites, as needed. /liliMaintain active and regular communication with site personnel and internal BeOne Medicines partners, with regular progress tracking and updates provided throughout the contract lifecycle. /liliPrepare subsequent contract amendments, note to files and other related contract documents, as needed. /liliEscalates contracting issues and/or potential delays to internal and external stakeholders, as necessary. /liliAttend and actively participate in Investigator Site, project related, CBO, and other meetings, as necessary. /liliUpdate 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 BeOne Medicines policies. /liliProvides a handoff to the project/payment team upon execution of a site’s final contractual documents. /li /ulh3Supervisory Responsibilities /h3pNone. /ph3Computer Skills /h3pMicrosoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, Sharepoint, etc. /ph3Other Qualifications /h3ulliGood knowledge of ICH-GCP, pharmaceutical related regulations and laws.
/liliGood understanding of clinical trial contracting process, and relevant clinical operation practices. /liliAwareness and understanding of compliance and regulatory matters in clinical research. /liliProven negotiation, interpersonal and business skills. /liliStrong planning and organizational skills and the ability to work independently and effectively in a dynamic environment with competing priorities. /liliSense of urgency and strong goal orientation; track-record of meeting deadlines and goals. /liliStrong 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. /liliProactive and positive team player. /liliAble to maintain high performance during times of ambiguity and change in the work environment. /liliExperience in financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable. /liliHas knowledge of Intellectual Property issues, Publication issues, Indemnification issues and other standard issues of site contracts within the clinical research area. /liliMust be willing to work in a fast-paced environment with time-sensitive material. /liliDemonstrated ability to work effectively at all levels of an organization. /li /ulh3Travel /h3pYes, 10%. /ph3Salary Range Spain /h3p57,600.00 EUR - 72,000.00 EUR. /ph3Global Competencies /h3ulliFosters Teamwork /liliProvides and Solicits Honest and Actionable Feedback /liliSelf-Awareness /liliActs Inclusively /liliDemonstrates Initiative /liliEntrepreneurial Mindset /liliContinuous Learning /liliEmbraces Change /liliResults-Oriented /liliAnalytical Thinking/Data Analysis /liliFinancial Excellence /liliCommunicates with Clarity /li /ulh3Equal Employment Opportunity /h3pBeOne 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
📌 Senior Contract Associate, Clinical Site Contracts (España)
🏢 BeOne Medicines ESP, S.L.U.
📍 España