Hybrid 3 days in office/up to 2 days WFH. Independently lead Medical Affairs + Health Impact (HI) funded research, including Externally Sponsored Collabs & Non-Interventional Studies (NIS) (single & multi-country) from inception to closure, in compliance with quality standards. Support strategic leadership of the Cross-Functional Team. Drive deliverables & timelines. Lead & manage meetings with stakeholders. Manage 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. Manage IP & study supplies. Support process improvement initiatives & serve as subject matter expert and/or mentor.
Must possess a Master's or foreign education equivalent & 2 years of clinical research work experience. Of work experience required, must have 5 years in each of the following: (i) applying standard quality procedures to MHI research, 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 across the globe; (iv) using 3 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, and/or central imaging; (v) managing meetings (creating agendas, preparing minutes, or presenting); (vi) analyzing & evaluating complex issues to accelerate study timelines & enable a well-run study; & (vii) ensuring data is clean, documents are accurate to maintain inspection readiness. Alternatively, would accept a Bachelor's or foreign education equivalent & 5 years of clinical research work experience. Of work experience required, must have 5 years in each of the following: (i) applying standard quality procedures to MHI research, 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 across the globe; (iv) using 3 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, and/or central imaging; (v) managing meetings (creating agendas, preparing minutes, or presenting); (vi) analyzing & evaluating complex issues to accelerate study timelines & enable a well-run study; & (vii) ensuring data is clean, documents are accurate to maintain inspection readiness. Work experience may be gained concurrently. Would accept combined education, training and work experience.
Apply online at https://abbvie.com/en or send resume to [email protected]. Refer to Req ID: REF49790R.
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