MSD Associate Clinical Operations Manager - II 

Poland, Masovian Voivodeship 

530100223

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, Head COMs or CRD, the person is responsible for execution and oversight of clinical trial country submissions and approvals.

• 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 Regulatory bodies for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country• Contributes to the development of local SOPs.
• Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country
deliverables are obtained for submissions and local milestones.
• Provide support and oversight to local vendors as applicable.
• 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 systems.
• Support of local regulatory compliance. Ability to in/directly influence investigators,
external partners and country operations.
• 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, Regulatory bodies 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/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.

• 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 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 oversight from COM Lead 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. Specific examples of common problems include: 1) Quality and compliance issues, 2) Regulatory and legal issues, and 3) 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 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.

• 2-3 years of experience in Clinical Research.
• Required: Associate Degree or equivalent Health Care related experience.
• Preferred: Bachelor’s degree.

Current Contingent Workers apply

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