Clinical Operations Manager
Clinical Operations Manager
Posted on :
03-06-2025
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1 Vacancy
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Job Description
We are looking for an experienced Clinical Operations Manager / CRA Line Manager who has project management and / or line management experience.
- Accountable for all activities of site related study execution of assigned studies / Monitors 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
- Oversee site evaluation/selection contracts/budget negotiation regulatory/EC submissions startup issue management relationship management monitoring and site closure. 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. May monitor regulatory reforms and industry trends within country / district 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
- Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals priorities and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions
- 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. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager.
Qualifications :
- Bachelors or equivalent degree in health related departments (e.g. Medical Scientific Nursing Pharmacy)
- Minimum 3 years of experience in site monitoring processes
- Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with experience leading country projects with competing deadlines
- Experience across multiple Therapeutic Areas and Study Phases
- Strong analytical and critical thinking skills
- 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
- Demonstrated business ethics and integrity
- Ability to drive continuous improvement and simplicity in process and having agility mindset and approach.
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
Employment Type
Full-time
Key Skills
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