This position will lead clinical research studies and activities. Will be involved in the planning, management, implementation and coordination of all stages of the clinical trials. This includes implementation of the study, coordination of members of the team, preparation of all clinical and regulatory documents and meetings, follow-up of progress, data management and reporting, and drafting the final report. The Clinical Project Manager will be responsible for ensuring that the milestones are completed according to agreed standards and timelines. As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, The Clinical Project Manager will oversee daily operations and activities of assigned services within the Sekaly team at CWRU as well to all clinical and laboratory sites at CWRU and outside of CWRU. The clinical project manager will be involved in clinical trials led by the Sekaly’s group in the areas of immunotherapy of cancer and HIV.
- Be the primary contact between Principal Investigator, NIH and other study teams, organize monthly meetings and follow overall and site project progresses Work in conjunction with Principal Investigator and NIH team to accomplish goals, projects and research initiatives for assigned Clinical Trial. Work collaboratively with all functional areas to facilitate teamwork and communication that will support the success of the clinical and research protocol. (25%).
- Oversee all aspects of the protocol development process including drafting of protocols, consent forms and their modifications as required. Oversee all aspects of clinical trials/research projects budgeting, salary planning, research expense accounting, and resolution of research related charges. Facilitate approval process with internal review board (IRB) at the PI site as well as regulatory compliance for the study and each site. (20%)
- Draft and maintain Management Plan in accordance with the Scope of Work, Project Plan and milestones; work with appropriate staff to develop, or/and follow up finalizing of all required documents (CRFs, Pharmacy Manual, Monitoring Plan, SOPs as required). (20%)
- Ensure an accurate plan for Production Site in concordance with Clinical Sites. Follows timely production, quality and distribution of the product. Monitor recruitment for each site, collect AEs and report to Principal Investigator and NIH. Oversee quality assurance functions for assigned services, lead/participate in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trial. (15%)
- Ensure accurate maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. Work closely with project teams to ensure timely resolution of research project issues related to development and setting up the projects, respect of timelines. Contribute to activities that will progress the availability of tools and programs that facilitate data acquisition, storage and sharing in close collaboration with Bioinformatic Department. (10%)
- Ensure study timelines are met, preparing yearly progress reports and final study reports, review the data and / or reports for accuracy and compliance. Ensure the proper filing, maintenance and archiving of study documentation, participate in proficiency assay groups and grant writing. (10%)
Assist the Principal Investigator as necessary.
Perform other duties as necessary.
Department: Daily contact with PI at Case and on sites.
University: Daily contact with Pathology Department
External: Daily contact with all clinical and laboratory sites
This position has no supervisory responsibility
Experience: 5-10 years of relevant experience in a scientific or clinical environment.
Education/Licensing: Master’s degree in life sciences or related field
- Effective written/verbal communication and oral presentation skills required. Excellent interpersonal, leadership, decision-making and issue resolution skills are also required.
- Understanding of regulated clinical trial environment and knowledge of drug development process
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Good leadership skills, with ability to motivate
- Good organizational and planning skills
- Understanding of study financial management
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Good attention to detail
- Proven ability to work on multiple projects balancing competing priorities
- Ability to meet consistent attendance.
- Ability to interact with colleagues, supervisors, and customers face to face.
General office working conditions.
Communicate by telephone, e-mail, and in-person discussions.
Standard 40-hour week.
Qualified applicants should send CV's to Betty Chartouni at email@example.com
In employment, as in education, Case Western Reserve University is committed to Equal Opportunity and Diversity. Women, veterans, members of underrepresented minority groups, and individuals with disabilities are encouraged to apply.
Case Western Reserve University provides reasonable accommodations to applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Inclusion, Diversity and Equal Opportunity at 216-368-8877 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.