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Job DescriptionnBrief Description of PositionnThe Clinical Research Director is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for Global Clinical Trials Operations country operations.

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Adherence to local and global policies and procedures to conduct high-quality, inspection ready studies are essential. The position is accountable for trial quality and audit responses and completion of Corrective and Preventive Action Plans. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of General Clinical Trials Operations within the country/cluster.

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The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage.

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Clinical Research Director is the primary country/ cluster level contact for Global Clinical Trials Operations and has the following key responsibilities

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- Supports the regional Global Clinical Trials Operations leadership team, leading strategic development of their country / cluster to deliver clinical trials as per global clinical research pipeline requirement
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- Strategic country / cluster representative for initiatives at all levels of the organization
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- Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed Global Clinical Trials Operations , Global Clinical Development , and Research Laboratories objectives
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- Leads strategic development and management of institutional & investigator relationships in conjunction with Research Laboratories / Global Clinical Director Therapy Areas, and when appropriate Human Health
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- Working with regional and global colleagues develops and executes the Global Clinical Trials Operations strategy for the country/cluster - such as Industry associations
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nLeadership and Management of the Global Clinical Trials Operations country / clustern

Organization

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- Recruits and hires talent
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- Proactively manages and develops talent
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- Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment
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- Creates an empowering, compliant, collaborative, and innovation-focused work environment
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- Builds a culture of quality and compliance through training, oversight, and collaboration
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- Oversight to ensure appropriate scientific and operational training for staff members.
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nClinical Operation Management Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of Global Clinical Trials Operations within the country/cluster.nLeadership and oversight of the followingn

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- Research Laboratories / Global Clinical Director / Global Clinical Trials Operations goals, initiatives and expectations
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- Development and delivery of company standards in given geography
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- Activities of all cluster/country level Global Clinical Trials Operations team & all programs and studies
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- Approved administrative budget to support Global Clinical Trials Operations team (e.g., salaries & travel)
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- Country level operational study budgets
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- Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory, Pharmacovigilance and Medical Affairs
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- Responsible and supports development of audit responses and completion of Corrective and Preventive Action Plans.
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nCollaborates and supportsn

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- Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate and
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nappropriate resourcing for company internal clinical trial portfolionn
- Clinical Research Organization, Regional and local Leadership to ensure the successful conduct of outsourced clinical trials
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nEngagement With Key External Stakeholdersn

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- Supporting Management and the clinical operations of studies managed by Global Clinical Trials Operations.
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- Support the development and management of Investigator and operational relationships in conjunction with all Research Laboratories Therapy Areas, and when appropriate Human Health colleagues
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- Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with Key Opinion Leaders, etc.).
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nQuality / Compliance Adherence / Standardn

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- Ensure that compliance, quality and timeline objectives are met for all trials executed in the country.
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- Sets clear

Postúlate en Kit Empleo: kitempleo.pe/empleo/wknlj

📌 Clinical Research Director, Peru (Lima)
🏢 MSD LATAM
📍 Lima