Medical Research Specialist
Medical Research Specialist
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Job Description
PRIMARY FUNCTION/OBJECTIVE
To manage medical research operations and executions including NIS collaborative research IIS and PAA in accordance with relevant SOPs and regulatory requirement.
CORE JOB RESPONSIBILITIES
- Conduct and manage medical research executions and represent the study operations on multifunctional stakeholders/platforms internally and externally
- Execute and oversee medical study operations with stakeholders partnership to ensure all NIS IIS PAA and evidence generation related activities are performed according to corporate ethical and legal requirements
- Conduct quality and compliance monitoring in medical research operations and coordinate with project stakeholders from study startup to closeout; and ensure quality in accordant with SOPs
- Monitor study data integrity and ensure the successful that meets company expectations with study operation deliverables timely reported per organization requirements
- Contribute to research core document and agreement management to ensure documentation and communication fulfill GCP legal and regulatory requirements
- Contribute to oversee and review study related documents from vendors
- Support in vendor contracting process and management
- Support in study budget planning process for long range planning (LRP) medical planning medical finance tracking and management and data generation/clinical trials planning
- Support in evidence generation related review in terms of publication review & approval
- Complies with company training assignments as required
Qualifications :
PREFERRED QUALIFICATIONS
- Bachelors degrees in Pharmacy Nursing or relevant scientific discipline. Masters degree in a scientific discipline will be preferred
- Significant clinical research experience for global studies 3 years) and experiences in late phase studies will be preferred particularly the experiences in Immunology Oncology and Neuroscience therapeutic areas
- Excellent knowledge of clinical research practices local regulations and ICH guidelines with solid experiences in the ethics committee and clinical study contracting processes
- Demonstrate superior leadership skills to drive project deliverables with good interpersonal and effective communication skills to engage with cross functional stakeholders
- Competent in skills of Project Management particularly in regard to management of schedule budget communication and quality
- Familiar with managing clinical study vendors and financial activities
- Fluent English with excellent verbal and written communication skills
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 :
Fulltime
Employment Type
Full-time
