Clinical Operations Manager – Budgets and Contracts
Job Description:
• Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality 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 align country timelines for assigned protocols
• Provides support and oversight 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.
• Delivers clinical and financial contracts within 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 Board (IRB) / Independent Ethics Committee (IEC) and Regulatory Authorities in submission and approval related interactions
Requirements:
• 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 impact 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 make decisions independently with limited oversight from SCOM or manager.
• Requires a strong understanding of local regulatory environment
• 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. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable.
• Effective and efficient time management, organizational and interpersonal skills, and conflict management skills
• High sense of accountability and urgency to prioritize deliverables
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills
Benefits:
• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options
Apply Now
Apply Now
• Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality 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 align country timelines for assigned protocols
• Provides support and oversight 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.
• Delivers clinical and financial contracts within 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 Board (IRB) / Independent Ethics Committee (IEC) and Regulatory Authorities in submission and approval related interactions
Requirements:
• 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 impact 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 make decisions independently with limited oversight from SCOM or manager.
• Requires a strong understanding of local regulatory environment
• 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. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable.
• Effective and efficient time management, organizational and interpersonal skills, and conflict management skills
• High sense of accountability and urgency to prioritize deliverables
• Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills
Benefits:
• Health insurance
• 401(k) matching
• Flexible work hours
• Paid time off
• Remote work options
Apply Now
Apply Now