Clinical Research Director, Peru

Job Description

Brief Description of Position
The 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.
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 Global Clinical Trials Operations within the country/cluster.
The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage.
Clinical Research Director is the primary country/ cluster level contact for Global Clinical Trials Operations and has the following key responsibilities:
- 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
- Strategic country / cluster representative for initiatives at all levels of the organization
- 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
- Leads strategic development and management of institutional & investigator relationships in conjunction with Research Laboratories / Global Clinical Director Therapy Areas and when appropriate Human Health
- Working with regional and global colleagues develops and executes the Global Clinical Trials Operations strategy for the country/cluster - such as Industry associations
Leadership and Management of the Global Clinical Trials Operations country / cluster

Organization:
- Recruits and hires talent
- Proactively manages and develops talent
- Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment
- Creates an empowering compliant collaborative and innovation-focused work environment
- Builds a culture of quality and compliance through training oversight and collaboration
- Oversight to ensure appropriate scientific and operational training for staff members.
Clinical 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.

Leadership and oversight of the following:
- Research Laboratories / Global Clinical Director / Global Clinical Trials Operations goals initiatives and expectations
- Development and delivery of company standards in given geography
- Activities of all cluster/country level Global Clinical Trials Operations team & all programs and studies
- Approved administrative budget to support Global Clinical Trials Operations team (e.g. salaries & travel)
- Country level operational study budgets
- 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
- Responsible and supports development of audit responses and completion of Corrective and Preventive Action Plans.

Collaborates and supports:
Functional Service Provider (FSP) Senior Regional and local Leadership to ensure adequate and
appropriate resourcing for company internal clinical trial portfolio
Clinical Research Organization Regional and local Leadership to ensure the successful conduct of outsourced clinical trials

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

Quality / Compliance Adherence / Standard:
- Ensure that compliance quality and timeline objectives are met for all trials executed in the country.
- Sets clear performance standards and holds self and organization accountable for achieving results. Embraces Global Clinical Trials Operations metrics and performance standards.
- Work collaboratively in a matrix organization with all groups within Global Clinical Trials Operations especially with Clinical Sciences and Study Management Clinical Quality Managers and Regional Operations Teams to deliver objectives
- Take responsibility for any clinical audits working closely with the Quality Assurance group and the Good Clinical Practice Quality and Compliance Council.

Qualifications Skills & Experience
CORE Competency Expectations:
Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within Global Clinical Trials Operations and Research Laboratories in a matrix organization.
Management expertise should cover management of budget travel resources headcount processes (and controls) productivity quality and project delivery
A complete understanding and Global/Regional/Local regulatory requirements is required.
Strong Communication skills requiring proficiency in written and spoken English and preferably local language. The incumbent must be competent and effective in written and verbal communication.
Strategic thinking

Behavioral Competency Expectations:
High emotional intelligence
Strong leadership that will attract motivate inspire develop and retain talented addition Leadership skills that enable and drive alignment with the goals purpose and mission of Research Labs Global Clinical Development and Global Clinical Trial Operations.
Positive proven success in people management

Educational Requirements:
Required:
Bachelors degree in Science or equivalent healthcare experience
Preferred:
Advanced degree (e.g. Medical Doctor Pharmacy MS MBA)
Complexity*

Small-sized country/ low to mid-complexity geography
Experience in Clinical Trials**

5 years or more
People management Experience
3 years or more
*Criteria for complexity includes:
Country/affiliate size
Team size
Product portfolio
Pipeline and clinical trials
Scientific research environment number of
local data generations
Our Company Investigator Studies
Programs
Access and healthcare policy environment
** Experience in Clinical Trial Operations gained from
working at hospitals and/or research institutions recognized
clinical trial suppliers/vendors reputable Clinical Research Operations and/or a
Sponsor environment working on multi-phase multitherapeutic
and diverse clinical trials from study initiation to
completion and associated regulatory submission and inspection preparation

Required Skills:

Preferred Skills:

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Relocation:

VISA Sponsorship:

Travel Requirements:

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