Senior Clinical Research Project Manager

$64,741 - $92,500/Yr

Northwestern University - Chicago, IL

Full-time - Mid Level

Chicago, IL

Educational Services

About the position

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.

Responsibilities

• 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.
• 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.
• Manages conduct of experimental tests & procedures.
• Closely monitors & documents patient's adverse events.
• Plan, conduct and close out of clinical studies in compliance with quality standards.
• Lead cross functional study team, Disease Team Meetings.
• 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.
• Proactively anticipate, identify, and address study related issues and opportunities for innovative solutions.
• 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.
• Responsible for quality control and inspection readiness at all times.
• Responsible for risk assessment, mitigation planning and execution.
• Prepare, oversee, and review documents that are related to assigned clinical study.
• 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.
• Attain clinical study's goals by working with other members of the study team.
• Work hand-in-hand with clinical trial managers and document control personnel.
• Analyzes, evaluates & interprets data to determine relevance to research.
• Prepares results & may co-author scientific papers for presentation & publication.
• Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.
• Ensures that all study documents associated with current local, state, & federal regulatory guidelines are completed in a timely manner.
• Manages project data including processing, accuracy, analysis & evaluation of data.
• Provides consultation to internal/external project staff on appropriate data management.
• Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines.
• Ensures appropriate allocation & compliance.
• Coordinates & participates in budgetary negotiations with industry sponsors.
• Acts as a mentor in regard to education of junior coordinators and project managers.
• Performs other duties as assigned.

Requirements

• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required.
• Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience.
• Supervisory or project management experience required.
• Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.

Nice-to-haves

• Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
• 2-3 years relevant leadership/management experience.
• Minimum 2 years of relevant experience with successful delivery of project study start-up.

Benefits

• Meaningful, competitive, high-quality health care plans.
• Retirement benefits.
• Tuition discounts.
• Flexible work arrangements.
• Programs to help locate and pay for quality, affordable childcare and senior/adult care.
• Comprehensive programs and services to help navigate life's challenges and opportunities.
• Support for employee career development.