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 execution quality in accordant with SOPs
- Monitor study data integrity and ensure the successful execution 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 serving our community and embracing diversity and inclusion. It is AbbVies 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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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
