Job Description
If you want to:
Join a multi-award-winning leading biopharmaceutical company
Be at the center of innovation
Be part of international team
Apply today!
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The person will be responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
You will be particularly responsible for:
Ownership of country and site budgets. Development, negotiation, and completion of Clinical Trial Research Agreements.
Overseeing and tracking clinical research-related payments. Payment reconciliation at study close-out. Maintenance of financial systems. Financial forecasting in conjunction with Sr.COM /other roles.
Execute and oversee clinical trial country submissions and approvals for assigned protocols.
Develop local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
Your key responsibilities:
Manage country deliverables, timelines and results for assigned protocols to meet country commitments.
Contribute to the development of local SOPs.
Coordinate and liaise with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Oversee and coordinate local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Work in partnership internally with GCTO 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. Through continual interaction with local clinical team/s successfully deliver clinical and financial contracts within fair market value.
Contribute strongly to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Contribute to COM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required.
You should apply if you have:
At least 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.
Expertise of core clinical systems, tools, and metrics.
Excellent English and Hungarian languages skills.
Strong coordination and organizational skills.
Skilled knowledge of budget and contract negotiations, local regulatory environment and submission processes, and understanding of how these impact study start-ups.
Ability to make decisions independently with limited oversight from Sr.COM or manager.
Strong understanding of local regulatory environment.
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
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.
Positive mindset, growth mindset, capable of working independently and being self-driven.
Who we are…
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for…
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Flex TimeShift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:R239998
