Country Clinical Operations Manager
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
To enable AbbVies 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 : 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Six Sigma
- Lean
- Management Experience
- Process Improvement
- Microsoft Outlook
- Analysis Skills
- Warehouse Management System
- Operations Management
- Kaizen
- Leadership Experience
- Supervising Experience
- Retail Management
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
