Senior Clinical Operations Manager
2 weeks ago
Purpose
Describe the primary goals, objectives or functions or outputs of this position.
To enable AbbVie' s emergence as a world class R&D organization, the position is accountable for all activities of site related study execution directly or by leadership of assigned staff involving start-up, execution, and close-out.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Accountable for all activities of site related study execution of assigned studies / staff involving start-up, execution, and close-out. Accountable for the on-time and within budget study execution of assigned projects, including but not limiting to country and site feasibility. 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. Stay abreast of new and/or evolving local regulations, guidelines and policies. Monitor regulatory reforms and industry trends within country / region, and provide impact analysis of significant changes affecting conduct of Clinical studies.
- Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation. Conduct trending, impact analysis and implement actions within country/district.
- Working with the Country/District Head, may be responsible for resource management of entire country/district. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie's research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provides solutions.
- Working with the Country/District Head, may be responsible for budget planning & oversight of expenses across country/district.
- Responsible for the acquisition and retention, performance management, and growth and development of talent.
- May be responsible for being the country point of contact for CROs for an assigned study / studies. Participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
- If assigned; Serve as key point of contact in country/district for clinical study programs. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
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 5 years plus at least 1 year of direct line management experience 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.
- Demonstrates/Drives continuous improvement and simplicity in process and approach and enhances agility.
- Demonstrated business ethics and integrity.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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