Job Description

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the COM Lead or CRD, the person is responsible for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities include, but are not limited to:

• Executes and oversees clinical trial country submissions and approvals for assigned protocols both under CTD and EU CTR.

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

• 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.

• Coordinates and liaises with CRM, CTC, CRA to ensure country deliverables are obtained for submissions 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 management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.

• 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.

• Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.

• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, EU regional and HQ functional areas and externally with vendors and sites, 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.
  

Core competencies:

• Expertise of core clinical systems, tools and metrics

• Excellent English skills

• Strong coordination and organizational skills

• Skilled knowledge of the regional and 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 COM Lead or manager.

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

• Requires strong understanding of regional and local regulatory environment

• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
  

Behavioural Competency Expectations:

• Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: Quality and compliance issues, Regulatory and legal issues, and issues related to functional area deliverables that could jeopardize protocol milestones.

• 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.
  

Experience Requirements: Required:

• 5 years of experience in clinical research with focus on regulatory aspects.

Educational Requirements: Required:

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

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:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):