Senior Start Up Specialist - ContractsMadrid, Community of MadridSenior Start Up Specialist - ContractsMadridMadrid, Community of Madrid, ESMAIN REQUIREMENT: experience in contract & budget negotiationThe Senior Start Up Specialist / COM is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Ability to indirectly influence investigators, vendors, external partners and country managers to deliver these commitments is amust. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country based regulations, laws and procedures with minimal support from the client management. The position requires skilled knowledge of budgetand contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables. The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. FINANCIAL (as applicable):- Assistance with the ownership of country and site budgets. - Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value. - Oversight and tracking of clinical research-related payments- Payment reconciliation at study close-out. COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS (as applicable):- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. - Development of local language materials including local language Informed Consents and translations. - Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols. MANAGEMENT & QUALITY OVERSIGHT:- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. - Contributes to the development of local SOPs. COLLABORATION:- Works in close collaboration internally with Clinical country operations, Country Quality Manager, Finance, client Medical Affairs, Regulatory Affairs, PharmacoVigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and RegulatoryAuthorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. - Collaborates closely with clientRegional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable. LOCAL PROCESS OVERSIGHT: (as applicable):- Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. - Enters and updates country information in clinical, regulatory, safety and finance systems. Labcorp Drug DevelopmentAs a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries. Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise. Did you know? In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023. We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement. Job SummaryJob number: 2330267Date posted : 2023-05-15Profession: ClinicalEmployment type: Full-Time#J-18808-Ljbffr
