Job Description
The Country Clinical Operations Manager is the key leader for Clinical Operations at the country level for both internal and external partners. Accountable for the strategic and operational management of clinical operations and clinical site management activities for the assigned country or countries. The role is responsible for leading the implementation of AbbVie's corporate vision and objectives, operating across all therapeutic areas to support the execution of AbbVie's pipeline. The Country COM is accountable for country clinical trial performance, providing strategic planning, oversight and direction to ensure on-tim e, within-budget, high-quality delivery of internally conducted clinical studies.
* Defines the country strategy and operational plans aligned with AbbVie's business priorities, Clinical Development Operations and affiliate objectives to position the country for near- and long-term success.
* Continuously assesses 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, conduct and closure), ensuring high quality and scientific integrity of trial deliverables. Accountable for all country-level CDO deliverables for internally managed clinical studies.
* Provides leadership and oversight to the clinical research team including, but not limited to:
* Performing accompanied visits (on-site and off-site).
* Accelerating AbbVie's priority programs through close collaboration with internal and external stakeholders.
* Conducting trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel.
* Driving performance and addressing gaps to ensure the team achieves country- and site-level KPIs, KRIs& metrics.
* Partnering with internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through contribution to the R&D portfolio success. Partners with the GMA Medical Affairs Head to co-lead the "One R&D" collaboration within the affiliate and operates as the CDO Head to represent non-CSM CDO personnel based within the affiliate.
* Accountable for the identification of resource needs, management of the allocated resources and timely hiring of clinical research staff to support clinical trial execution. Responsible for maintaining team capacity aligned with organizational needs, applying flexible and effective approaches for responsibilities assignment that promote staff development and retention.
* Defines and implements the optimal team organizational structure to support the needs of the business, allowing 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 and ensuring 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 focused on continuous improvement and excellence.
* Ensures inspection readiness across all activities, through effective leadership and oversight, promoting quality-driven initiatives. Responsible for the development of a critical-thinking organization focused on gap assessment, risk identification and mitigation strategies. Acts as the country expert for audit and inspection related processes and may serve as the local AbbVie host for in-country inspections/audits.
* Accountable for functional budget planning and management, ensuring accurate budgets and forecasts. Works closely with finance counterparts, guaranteeing seamless budget control processes and accurate communication of budget status, cost and issues to allow timely decision-making.
* Responsible for country feasibility, site selection strategy, and expanding AbbVie's site footprint within the country to support the pipeline.
Qualifications
* Education: Bachelor’s or equivalent degree in a health-related field (Medical, Scientific, Nursing, Pharmacy) preferred.
* Strong experience in clinical research, demonstrating a high level of expertise in study monitoring and management across multiple therapeutic areas, study phases and fully cyclical processes (start-up to close-out). Solid understanding of drug development and requirements such as GCP, ICH, etc. Robust knowledge of local clinical trial settings (regulatory and healthcare environment).
* 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.
* Proven track record in project management with strong planning and organizational skills and a high level of adaptability in a dynamic environment with experience leading projects with competing deadlines.
* Experience in setting and driving the strategy and leading the management and completion of global trials assigned to the country or countries. Experience in functional budget planning, resource planning & assignment, and quality management at the country or regional level.
* Strong leadership competencies. Robust experience in leading teams through change, leveraging team contribution to support business strategies.
* Fosters an environment that promotes the sharing of ideas, information and best practices (internal and external) to drive continuous improvement.
* Proven leadership skills in a cross-functional, matrix environment, with ability to influence and align key stakeholders, forge strong partnerships where needed and promote seamless collaboration at all levels.
* Proactive response to the needs of others and ability to make own needs and business strategy known.
* Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision-making.
* Excellent interpersonal skills with the ability to communicate persuasively in a succinct and comprehensive manner to colleagues at all levels. Engenders trust throughout the organization and seeks to grow and stretch key talent for future possibilities.
* Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
* Mandatory hybrid model based in Maidenhead office Tuesday–Thursday.
Additional Information
AbbVie is an equal‑opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.
US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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