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MSD este o companie biofarmaceutică globală care dezvoltă medicamente și vaccinuri pentru provocări majore din domeniul sănătății, inclusiv cancerul, bolile infecțioase, afecțiunile cardiovasculare și metabolice, precum și îngrijirea axată pe prevenție. Cunoscută sub numele Merck & Co., Inc. în Statele Unite, Canada și Puerto Rico, MSD îmbină cercetarea științifică cu expertiza în dezvoltare și comercializare pentru a oferi soluții de îngrijire a sănătății oamenilor și animalelor.
Activitatea sa acoperă domeniile Sănătății Umane, Sănătății Animalelor și Cercetării și Dezvoltării, creând oportunități pentru profesioniști din echipe științifice, clinice, comerciale, operaționale și corporative. Prin activitățile desfășurate în regiuni din întreaga lume, carierele la MSD reflectă accentul pus pe cercetare, colaborare, incluziune și progres responsabil în domeniul sănătății globale.
Clinical Operations Manager, Finance
Manage clinical trial contract negotiations and budgets for MSD. Support compliant site agreements, financial deliverables, and study start-up.
Descriere
- Oversee assigned protocols for compliance with ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting requirements.
- Prepare, analyze, negotiate, and execute site agreements and budgets throughout the contract cycle.
- Apply legal fallback language and budget parameters, escalating site-specific compliance issues.
- Maintain contract, approval, and budget records using consistent naming and savings conventions.
- Track documents and metrics to support timely execution of site agreements.
- Conduct quality checks before agreements are executed.
- Coordinate Site Ready Deliverables with CRM, CTC, CRA, COM-R, finance, and legal teams.
- Identify risks and put mitigation plans in place to meet country timelines and commitments.
- Build relationships with investigational sites and Site Management Organizations.
- Contribute to the development of local SOPs.
- Review and negotiate Site Access Forms, EMR Access Forms, and institutional policies; escalate issues and facilitate approvals.
- Work with Payment Coordinators and CTC-Fs on contingency approvals, troubleshooting, and agreement amendments.
- Lead or contribute to business initiatives and projects.
- Serve as a process subject matter expert, sharing practices, recommending improvements, and providing training.
- Mentor team members and share best practices.
- Influence investigators, external partners, and country operations to deliver clinical and financial contracts within fair market value.
- Collaborate with global clinical operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters, vendors, and sites.
Cerințe
- Bachelor’s degree or higher.
- At least 3 years of experience negotiating contracts or budgets.
- Expertise with core clinical systems, tools, and metrics.
- Strong verbal and written influencing skills, with experience in training and mentoring in the local language and English.
- Strong coordination and organizational abilities.
- Knowledge of budget and contract negotiation and how these affect study start-up.
- Ability to influence investigators, vendors, external partners, and country managers with minimal support.
- Ability to make independent decisions with limited oversight.
- Ability to develop risk management and mitigation plans and resolve issues locally.
- Ability to lead a team of CTCs, as applicable.
- Problem-solving, time management, organizational, interpersonal, and conflict-management skills.
- Strong communication, leadership, negotiation, influencing, and training and mentoring skills.
- Ability to manage multiple deliverables and protocols in a remote virtual environment.
- Ability to work independently and take initiative.
- Juris Doctor (JD) preferred.
- Visa sponsorship is not available.
- Applicants must reside in the United States or Puerto Rico.
Beneficii
- Annual bonus and long-term incentive, where applicable.
- Medical, dental, vision, and other insurance coverage for employees and their families.
- Retirement benefits, including a 401(k).
- Paid holidays.
- Vacation leave.
- Compassionate and sick leave.
- Remote work arrangement.
- Relocation is not required.
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