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

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