Chicago, IL, 60684, USA
10 hours ago
Senior Research Project Manager
Job Title: Senior Research Project Manager Job Description We are seeking a Senior Research Project Manager to oversee complex biomedical and social-behavioral research studies. This role involves managing multiple investigators, teams, sites, sub-contracts, participants, and multi-million dollar budgets. You will ensure the completion of contract requirements and client specifications while overseeing day-to-day operations and securing needed resources. Responsibilities + Plan, develop, and implement new processes and protocols to support research studies. + Serve as the main start-up point of contact for both internal and external stakeholders. + Oversee the development and implementation of the start-up strategy with cross-functional teams. + Provide support to other project managers during the feasibility and financial resourcing tasks of the start-up phase. + Collaborate with nursing staff and Principal Investigators to ascertain pretreatment and eligibility requirements, interview participants, and obtain social and medical histories. + Ensure compliance with study protocols and appropriate regulations, and recommend necessary revisions. + Manage experimental tests and procedures, closely monitor and document patient adverse events, and partner with nursing staff to modify dosages and schedules. + Plan, conduct, and close out clinical studies in compliance with quality standards (ICH/GCP, Global Regulations). + Lead cross-functional study teams and actively manage and track study milestones. + Provide regular updates on study status and progress to cross-functional teams, stakeholders, and governance bodies. + Develop clinical study design and associated systems and documents. + Proactively identify and address study-related issues and opportunities for innovative solutions. + Act as the single point of contact and decision-maker for operational aspects of the study. + Initiate and participate in the creation of innovative solutions and process improvement initiatives. + Ensure quality control and inspection readiness at all times. + Conduct risk assessment, mitigation planning, and execution. + Prepare, oversee, and review documents related to the assigned clinical study. + Organize clinical study meetings as necessary. + Ensure the availability of necessary resources for executing clinical projects. + Resolve issues and take part in procedure improvement initiatives. + Track logistics of samples and communicate results effectively with data analysts. + Work with the study team to outline priorities and resolve conflicts. + Manage documents related to the clinical study with clinical trial managers and document control personnel. + Analyze, evaluate, and interpret data to determine relevance to research. + Prepare results and co-author scientific papers for presentation and publication. + Act as a liaison between sponsoring agencies, collaborating organizations, and research or educational institutions. + Ensure all study documents comply with local, state, and federal regulatory guidelines and research protocols. + Manage project data, ensuring accuracy, analysis, and evaluation meet project objectives. + Provide consultation on data management and analysis to internal and external project staff. + Monitor and report on clinical trials, including budgets and timelines. + Ensure appropriate allocation and compliance during budgetary negotiations with industry sponsors. Essential Skills + Bachelor's degree. + 1-2 years of experience working on drug or device studies. + Experience with protocols, patient recruitment, and electronic medical records (EMR). + Oncology experience preferred, but cardiology or neurology is acceptable. Additional Skills & Qualifications + Experience with clinical data, monitoring tools, clinical research, and patient recruitment. + Knowledge of GCP, regulatory compliance, and CRC processes. + Skills in pre-screening patients, chart review, recruitment, data entry, phlebotomy, and project management. + Experience with multi-site studies and industry-based studies. Pay and Benefits The pay range for this position is $40.00 - $45.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Chicago,IL. Application Deadline This position will be accepting applications until Jan 23, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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