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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.

Under the oversight of the Head COMs, 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.
• 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.
• Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure

country deliverables are obtained for submissions, budgets, CTRAs and local milestones.

Collaborates closely with Headquarter to align country timelines for assigned protocols.

• Provide 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.

• 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 and

adheres to budget targets and agreed payment timelines.

• 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.

• 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.

Secondary Language(s) Job Description**:

Core competencies:

• Expertise of core clinical systems, tools and metrics

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Excellent verbal and written influencing and training/mentoring skills, in local language and English:

• 
  Strong coordination and organizational skills:
• Skilled knowledge of submission and approval processes and understanding of how these impact study startup.
• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with mínimal 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 proactively 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) Quality and compliance issues,

2) Regulatory and legal issues

3) issues related to functional area deliverables that could jeopardize protocol milestones.

• Effective and efficient time management, organizational and interpersonal skills, conflict management and problemsolving 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 selfdriven
• Able to directly influence site staff

Experience Requirements:

Required:

-
5 years of experience in clinical research or combined experience in Clinical Research
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