at Northwestern University in Chicago, Illinois, United States
Job Description
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Job ID50446
LocationChicago, Illinois
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Department: MED-Cancer Center
Salary/Grade: EXS/8
Job Summary:
Manages activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/ interventions; &/or multi-million dollar budgets.Ensures completion of contract requirements & client specifications.Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. Lead and support studies with high complexity including early phase studies, National trials,investigator initiated studies where our PIs hold the IND and have multiple affiliates.Study Project Manager must apply scientific expertise, strategic thinking, analytical skills, global mindset, and innovative solutions to proactively manage study risks and anticipate challenges. This role is fundamental to the future success of the study and requires you to take overall responsibility for and co-ordination of the risk management analysis, mitigations and reporting during the Start Up phase. Oversees
Specific Responsibilities:
Technical
Plans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.
Serve as the main start up point of contact for both internal and external stakeholders
Take oversight of development and implementation of the start-up strategy with cross functional teams
Provides support to the other project managers around feasibility and financial resourcing tasks during the start up phase
Oversees completion of study activities per protocol.Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.
Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.Manages conduct of experimental tests & procedures.Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.
Plan, conduct and close out of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)
Lead cross functional study team, Disease Team Meetings, actively manage and track study milestones and critical path activities
Provide regular updates on study status and progress to cross functional teams, stakeholders, and governance bodies
Development of the clinical study design and associated systems and documents; ICF, eCRF, IRT, CSR, etc.
Proactively anticipate, identify, and address study related issues and opportunities for innovative solutions and best practices
Single point of contact and decision maker for operational aspects of the study.
Point of escalation for any study activation feasibility issues
Initiate and actively participate in creation of innovative solutions and process improvement initiatives beyond his/her studies.
Responsible for quality control and inspection readiness at all times
Responsible for risk assessment, mitigation planning and execution
Administrative
Prepare, oversee, and review documents that are related to assigned clinical study (NDA, etc.)
Arrange or help in organizing clinical study meetings, as necessary
Ensure the availability of necessary resources for the execution of clinical projects
Answerable to questions and issues brought up by vendors and external consultants
Oversee the pattern and manner in which clinical research study is being conducted
Fully involved in resolving issues; take part in procedure improvement initiatives
Track logistics of samples and communicate those results effectively with the data analysts, etc.
Attain clinical study's goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
Work... For full info follow application link.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply.
