Country Clinical Operations Manager

2 weken geleden

Hoofddorp, Nederland AbbVie Voltijd

**Bedrijfsomschrijving**
**Vacatureomschrijving** Country Clinical Operations Manager (Team of 15)**
- Reporting to the Regional Head of Clinical Site Management.
- Based in the offices in Hoofddorp, Netherlands (3 days a week) with 2 days flexible working.
- Highly competitive salary, Lti’s, Bonus and comprehensive benefits package.

**Overview**:
The Country Clinical Operations Manager is the key leader for Clinical Operations at the country level for both internal & external partners. Accountable for the strategic and operational management for clinical operations and clinical site management activities for the assigned country.

Responsible for leading the implementation of the corporate vision and objectives, operating across all therapeutics areas to support the execution of AbbVie's pipeline.

The role is accountable for country clinical trial performance, providing strategic planning, oversight and direction of the country team to ensure on time, within budget and quality delivery of internally conducted clinical studies.

The Country COM is accountable to develop a highly collaborative framework with internal and external key stakeholders across the local and global organization to best position AbbVie in advancing clinical research and accelerating the transformation of science into best-in-class medicines.

**Key responsibilities include**:

- Defines the country strategy and operational plans aligned with AbbVie's business priorities, Clinical Development Operations and affiliate objectives in order to position the country for near and long term success.
- Continuously assess country site footprint across all therapeutic areas, expanding where there are opportunities and needs to support the pipeline.
- Provides leadership, strategic direction and oversight for all country activities across all stages of the clinical trial (country & site feasibility, selection and start-up, throughout study conduct and closure), ensuring high quality and scientific integrity of trial deliverables. Accountable for all Country level CDO deliverables for internally managed Clinical Studies.
- Provide leadership and oversight to the clinical research team including, but not limited to:

- performing accompanied visits (on-site and off-site)
- accelerate AbbVie's priority programs through close collaboration with internal and external stakeholders
- conduct trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel
- drive performance and address gaps to ensure the team achieves country and site level KPIs, KRIs & metrics
- Partners with internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through the contribution to the R&D portfolio success. Partners with GMA Medical Affairs Head to co-Lead the 'One R&D' collaboration within the affiliate. Operates as 'CDO Head' to support and represent non-CSM CDO personnel based within the affiliate.
- Defines and implements the optimal team organizational structure to support the needs of the business which allows the team to operate in a matrix and evolving environment, ensuring effective collaboration with key capabilities and roles. Identifies and implements strategies and tactics to ensure continuous efficiency, effectiveness and productivity of the country. Responsible for building a high performing team, accountable for the operational excellence in the execution of clinical trials.
- Accountable for ensuring adherence to applicable global and local regulations, ICH Guidelines and AbbVie Quality Management System, promoting a quality driven local organization, oriented to continuous improvement and excellence. Accountable for country Intelligence and impact analysis of all significant changes affecting the conduct of clinical studies, and for implementing procedural adjustments and orientation to guarantee team preparedness, alignment and compliance, as needed.

**Functie-eisen** Qualifications, Knowledge and Experience**
- Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Minimum of 5 years of work experience in clinical research, demonstrating a high level of expertise on study monitoring and management across multiple Therapeutic Areas, Study Phases and in fully cycle (startup to closeout) processes. Solid understanding of drug development process (and medical device preferred) and requirements such as GCP, ICH, etc. Robust knowledge of local clinical trial setting (regulatory and healthcare environment).
- At least 2 years of experience in line management of staff including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred.
- Proven track record in project management, strong planning and organizational skills and a high level of adaptability in a dynamic environment with experience l

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