COM

Job Description

Responsibilities include, but are not limited to:

•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.

• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.

• Contributes to the development of local SOPs. Oversees CTCs as applicable.

•Provide support and oversight to local vendors as applicable.

• 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.

• Works 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

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

• 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 Sr.COM or manager.

• Ability to make decisions independently with limited oversight from Sr.COM or manager.

• Requires 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

Behavioural Competency Expectations:

• Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.

• 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

Experience Requirements:

Strong experience in clinical research or combined experience in Clinical Research

Educational Requirements:

Required: Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros. Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificado.

LI-DNI

Additional location(s) Compensation Information:

Required Skills

• Adaptability, Business Management, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Conflict Management, Cross-Cultural Awareness, Growth Mindset, Influencing Skills, Patient Recruitment, Situational Leadership, Team Organization, Vendor Management, Working Independently

Preferred Skills:

• 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:

• Regular

Relocation:

• No relocation

VISA Sponsorship:

• No

Travel Requirements:

• No Travel Required

Flexible Work Arrangements:

• Not Applicable

Shift:

• Not Indicated

Valid Driving License:

• No

Hazardous Material(s):

• no

Job Posting End Date:

• 10/31/2026*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.