aCOM-II

Job Description

Responsibilities include, but are not limited to:

• Contribute to Execution and oversight clinical trial country submissions and approvals for assigned protocols.

• Develops local language materials including local language Informed Consents and translations.

• Interact with IRB/IEC and Regulatory Authority for assign ed protocols.

• Manages country deliverables, timelines and results for assign ed protocols to meet

country commitments. Responsible for quality and compliance in assign ed protocols in

country.

• Contributes to the development of local SOPs.

• Support of local regulatory and financial compliance. Ability to in/directly influence

investigators, external partners and country operations

• Works in partnership internally with GCTO country operations, finance, regulatory affairs,

pharmacovigilance, leg al and regional operations, HQ functional areas and externally withvendors 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/supporting 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 sharing best practices as appropriate/required.

• May act as buddy / mentor

Skills

• Good IT skills (MS office, Clinical IT applications) and ability to adapt to new IT applications on various devices.

• Knowledge of core clinical systems, tools and metrics

• Excellent verbal and written skills, in local language and English

• Strong coordination and organizational skills

• Knowledge of local regulatory environment and submission and approval processes, and understanding of how this 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 oversight from Sr.COM or Manager.

• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. ICH/GCP knowledge appropriate to role. Good knowledge of Good Documentation Practices

• Able to work with other experienced clinical research professionals and manage select protocols independently. Works with high quality and compliance mindset.

• Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, contribute to root cause analysis, and propose solutions to problems and escalate to management as applicable.

• 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 and negotiation skills as well as developing skills in influencing and training/mentoring, 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

Qualification & Experience:

• Required: Associate degree or equivalent Health Care related experience

• Advanced english

• Preferred: Bachelor’s degree

• 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, Adaptability, Business Agility, Clinical Research, Clinical Site Monitoring, Clinical Study Management, Clinical Trial Compliance, Competency Management, Compliance Activities, Contingency Plan, Data Analysis, Drug Development Research, Good Clinical Data Management Practice (GCDMP), Government Regulation, Influencing Skills, Interpersonal Relationships, Management Review, Negotiation, New Technology Integration, Proactive Thinking, Project Management, Risk Avoidance, Root Cause Identification, Schedule Adherence, Task Management {+ 2 more}

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.