CLINICAL OPERATIONS MANAGER FINANCE H859

Sólo Para Miembros Registrados


Job summary This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Responsibilities include, but are not limited to: Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA). Enters and updates country information in clinical and finance systems. Works in partnership internally with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions. Contributes to the development of local SOPs. Oversees CTCs as applicable. Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols. Adheres to budget targets and agreed payment timelines. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value. Contribute or lead initiatives and projects adding value to the business, as appropriate/required. Contributes strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Contributes to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required. Core competencies: Expertise of core clinical systems, tools and metrics. Excellent verbal and written influencing and training/mentoring skills, in local language and English. Strong coordination and organizational skills. Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Sr.COM or manager. Ability to make decisions independently with limited oversight from Sr.COM or manager. Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. Ability to lead a team of CTCs as applicable. Problem solving is essential to this position. Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills. High sense of accountability and urgency in order to properly prioritize deliverables. Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English. Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people. Positive mindset, growth mindset, capable of working independently and being self-driven. Able to directly influence site staff. 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business. Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience. Adaptability, Adaptability, Clinical Research, Clinical Site Management, Clinical Testing, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Management Processes, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Cross-Cultural Awareness, Customer Experience Management, Economic Forecasting, Financial Administration, Financial Forecasting, Global Sourcing, ICH GCP Guidelines, Management Process, Negotiation, Patient Recruitment, Problem Solving, Proven Commitment. A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R362337 Descripción del trabajo Lorem ipsum dolor sit amet , consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. 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