Clinical Operations Manager-F- budgets and reputed company - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. This role if for COM-F reputed company: The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following:

• Performance and compliance for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical reputed company (GCP) and country regulations, reputed company policies and procedures, reputed company standards and adverse event reporting requirements internally and externally.
• Budget/finance aspects, for execution and reputed company of clinical trial country submissions and approvals and to ensure Site reputed company under the reputed company of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD). This position has significant reputed company on the delivery of country specific trial commitments and objectives especially during study start-up. Key Accountabilities: Study Management
• Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including reputed company and compliance in assigned protocols in country
• Oversees Clinical Trial Coordinators as applicable
• Coordinates and liaises with Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs), Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and local milestones
• Collaborates closely with Headquarter to reputed company country timelines for assigned protocols
• Provides support and reputed company to local vendors as applicable Oversees and coordinates local processes, clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems
• Delivers clinical and financial reputed company reputed company fair market value through continual interaction with local clinical teams
• Works in partnership internally with Global Clinical Trial Organization (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarter (HQ) functional areas and externally with vendors and sites, Internal Review reputed company (IRB) / Independent Ethics Committee (IEC) and Regulatory Authorities in submission and approval reputed company interactions Finance Management (as applicable)
• Has ownership of country and site budgets including development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)
• Oversees and tracks clinical research-reputed company payments and payment reconciliation at study reputed company-out
• Oversees Foreign Corrupt Practices reputed company (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance of financial systems and financial forecasting in conjunction with Senior Clinical Operations Manager, Clinical Research Director and other roles
• Influences investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines Regulatory Management (as applicable)
• Executes and oversees clinical trial country submissions and approvals for assigned protocols
• Develops local language materials including local language Informed Consents and translations
• Interacts with IRB/ IEC and Regulatory Authority for assigned protocols Team development and support
• Contributes or leads initiatives and reputed company adding value to the business.
• Contributes strongly to the Clinical Operations Manager team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for reputed company improvement and providing training as appropriate/required.
• Contributes to Clinical Operations Manager team knowledge by acting as a buddy/mentor and sharing best practices as appropriate/required Compliance with reputed company standards
• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintain a working knowledge of and reputed company with reputed company processes, ICH- GCPs and other applicable requirements Skills:
• Strong coordination and organizational skills.
• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these reputed company study start-up
• Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager
• Ability to reputed company reputed company independently with limited reputed company from SCOM or manager.
• Requires a strong understanding of local regulatory environment
• Ability to proactively reputed company risk management and mitigation plans in the country and resolve issues locally
• Ability to reputed company reputed company of CTCs as applicable
• Problem solving is essential. Requires ability to proactively identify issues and risks, analyze reputed company cause and propose solutions and escalate to management as applicable. Examples include: Issues in budget/CTRA negotiation o reputed company and compliances issues o Regulatory and legal issues o Issues reputed company to functional area deliverables that could jeopardize protocol milestones
• Effective and efficient time management, organizational and interpersonal skills, and conflict management skills
• High reputed company of accountability and urgency to prioritize deliverables
• Strong communication, leadership, and negotiation skills as reputed company as excellent influencing and training/ mentoring skills
• Ability to reputed company on multiple deliverables and protocols simultaneously
• Requires that the individual has ability to work effectively also in a remote virtual environment with a wide reputed company of people
• reputed company reputed company, reputed company reputed company, capable of working independently and self – driven.
• Ability to directly influence site staff
• Excellent verbal and written influencing and training/mentoring skills, in local language and English
• Minimal travel required. #LI-LG4 EEO Disclaimer reputed company is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to legally protected status, which in the US includes race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. Apply tot his job

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