Abbott
healthcare
ClinicalAffairs:ClinicalProjectManager
“Clinical Affairs: Clinical Project Manager at Abbott. Skills: project management, clinical trial management. plan, prepare and execute high quality large scale and/or complex clinical program(s). ensure the trial is “audit ready” at all times”
What You'll Achieve.
completion of deliverables in a timely fashion within an agreed project timeline; attainment of project deliverables; trial is “audit ready” at all times
Industry & Context.
identification of project risks; development and implementation of the mitigations for these risks; corrective action plans at individual sites and across trial
approximately 30 - 50% travel to research laboratory or hospital settings, meetings and other Abbott facilities, Potential exposure to blood borne pathogens and other potentially infectious materials
What They're Looking For.
Must Have
Bachelor's-level degree required, 8+ years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials, 3+ years experience managing projects, 3+ years experience working with clinical professionals within a team, 3+ years experience working in a cross-functional product development setting
Nice to Have
Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred, Masters-level degree (or equivalent), or qualification in clinical trial management / medicine preferred, Previous experience with complex, global trials is preferred
What You'll Do.
prepare and execute high quality large scale and/or complex clinical program(s)
ensure the trial is “audit ready” at all times
writing of clinical project deliverables such as protocols
Directs forecasting of devices necessary for project in collaboration with supply-chain
Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
identification of project risks
development and implementation of the mitigations for these risks
corrective action plans at individual sites and across trial
How You'll Work.
Team & Collaboration
Leads the clinical project team members toward completion of deliverables in a timely fashion within an agreed project timeline; Internally interfaces with data management, biostatistics, clinical research associates, business leads, medical directors, functional management; acts as a company liaison with site investigators and clinical site staff; Leverages resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables; Responsible for effective communication within the Clinical Project Team and with functional management; Provides regularly updates regarding the status and progress of the trials; Supports the coordination and attends investigator and coordinator meetings, representing the clinical project team; May participate in internal/external trial-related audits; coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable company’s SOPs and policies
Communication Scope
Good verbal and written communication and presentation skills
Process & Methodology
project management, plan, prepare and execute high quality large scale and/or complex clinical program(s), Manages the program(s) within the approved budgets and timelines, identification of project risks, development and implementation of the mitigations for these risks, corrective action plans at individual sites and across trial, Demonstrated previous success managing multiple, complex, and international projects
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