Study Management Associate SMA II
Study Management Associate SMA II
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Key Responsibilities
- Contribute to global clinical trials from inception to closure with support from the Study Project Manager (SPM) & in compliance with quality standards.
- Responsibilities include but are not limited to:
- Drive deliverables & timelines;
- lead & manage meetings with stakeholders;
- Manage vendors recruitment CTMS & eTMF; Maintain Inspection Readiness;
- identify mitigate & manage risks;
- Develop & manage study materials;
- provide training to stakeholders;
- Support EDC IRT & ePRO design specifications user acceptance testing plans & key risk indicators & system management activities;
- manage IP & study supplies;
- Support process improvement initiatives & serve as a subject matter expert &/or mentor.
Qualifications :
Education & Experience
Must have a Bachelors or foreign education equivalent & 2 years of clinical research work experience. Of work experience required must have 2 years in each of the following: (i) applying standard quality procedures to full clinical trials including SOP ICH/GCP Global Regulations; (ii) working with ICFs protocols & amendments; (iii) functioning independently in a matrixed environment with teams in multiple time zones; (iv) using 1 or more of the following clinical trial systems or vendors: EDC IRT TMF ePRO CTMS central labs &/or central imaging; (v) analyzing & evaluating complex issues to accelerate study timelines & enable a wellrun study; (vi) managing meetings (creating agendas preparing minutes or presenting); & (vii) ensuring data is clean documents are accurate to maintain inspection readiness.
Work experience may be gained concurrently. 100 Telecommuting permitted.
Additional Information :
Salary Range: $106296 $153000 per year.
(Multiple/3 positions available)
Apply online at Refer to Req ID: REF37788P
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our shortterm and longterm incentive programs.
AbbVie 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.
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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No
Employment Type :
Fulltime
Employment Type
Full-time
