Country Clinical Operations Manager

Company Description

AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

To enable AbbVie’s emergence as a world class R&D organization, the Site Management and

Monitoring (SMM) Country/District COM plays a leadership role accountable for driving the business

of SMM within a Country/District(s) by providing oversight and direction to SMM staff; accountable

for the on time, within budget and quality delivery of the clinical studies. Promotes best practice;

identifies infrastructural improvements and implements action plan to ensure Clinical Field

Operations (CFO) and business objectives are successfully met; ensures alignment of local activities

with regional/global initiatives. The role reports into the Site M&M Leadership and serves as a single

point of accountability for the SMM deliverables within a Country/Disitrct(s) and influences and

aligns within Development Operations, and with Global Medical Affairs (GMA), and other key

stakeholders across the organization.

Responsibilities :

List up to 10 main responsibilities for the job. Include information about the accountability and

scope.

Manages/oversees site/country or district related activities as they relate to AbbVie clinical studies

(e.g. country feasibility, site evaluation/selection and activation, contracts/budget negotiation,

regulatory/EC submissions startup, issue management, relationship management, monitoring, site

closure). Accountable for the on-time and within budget execution of all clinical trials within a

Country/District(s). Provide local regulatory and legal requirement expertise.

Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices

(GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to

quality standards in conducting clinical research. Monitor regulatory reforms and industry trends

within country / region. Conduct and/or implement impact analysis of all significant changes to

conform with updated regulatory / industry regulations affecting conduct of clinical studies.

Ensures audit and inspection-readiness at all times. Country contact for regulatory agency

questions related to monitoring processes and procedures. Drive CAPA preparation and

implementation.

Accountable for managing country/district resources including need identification, timely hiring and

allocation, and managing changes to hiring plan. Responsible for staff recruitment and retention

plans.

Accountable for functional budget planning and administration.

Provide leadership to the Country/District and be accountable for growth and development of a

world class workforce that role models AbbVie behaviors.

Drives a learning environment and ensures continuous improvement in Country/District(s)

performance by using innovative approaches, active analysis of Key Performance Indicators,

metrics and milestones. Driving simplicity in process and approach, and enhancing agility.

Accountable for ensuring SITE M&M leadership, collaboration and teamwork across all key

stakeholders within the Country(s).

May lead global Task Forces and Initiatives. Interacts with peers within the industry to stay

abreast of regulatory landscape, raise AbbVie’ s profile in the R&D community. Accountable for

driving affiliate R&D Community goals in partnership with GMA.

Qualifications

Qualifications :

List required and preferred qualifications up to 10). Include education, skills and experience.Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing,

Pharmacy) preferred.

Site Monitoring Experience: Minimum 3 years. Preferably having monitored and/or managed a

study within a Country from start to close.

Experience in functional budget planning, resource planning & assignment, quality management in

a Country lead capacity preferred.

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.

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 and with clarity,

flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated

proactive and positive team player.

Exhibits strong planning and organizational skills and high level of flexibility in a dynamic

environment with experience leading (within country or region) projects with competing deadlines;

Experience across multiple Therapeutic Areas and Study Phases.

Demonstrating business ethics and integrity.

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