Clinical trial project manager overseeing the efforts of a cross-functional project team and accountable for clinical trial project profitability, quality and on-time delivery while striving to exceed client expectations. Respiratory or infectious disease experience desired as well as background in leading large, global projects. Ensure that project staff and functional leads (Clincal Lead, Data Manager, Start-Up Lead, etc.) deliver their respective job responsibilities according to project scope and budget with high quality.
location: Durham, North Carolina
job type: Contract
salary: $89.78 - 105.63 per hour
work hours: 9 to 5
Clinical trial project manager overseeing the efforts of a cross-functional project team and accountable for clinical trial project profitability, quality and on-time delivery while striving to exceed client expectations. Respiratory or infectious disease experience (particularly large seasonal and / or vaccine trials) highly desirable as well as background in leading large, global projects in a CRO or sponsor company setting. Ensure that project staff and functional leads (Clinical Lead, Data Manager, Biostats Lead, Start-Up Lead, Third Party Vendors, etc.) deliver their respective job responsibilities according to project scope and budget with high quality.
- Indirectly manage staff in accordance with organizations policies and applicable regulations.
- Responsibilities include planning, assigning, and directing project team; primary point of contact for sponsor and project-related escalation / issue management; risk and quality management and oversight of project deliverables and team performance.
- Resource and financial forecasting and management of project finances.
- Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
- Participate in the allocation and study-specific training of project resources.
- Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
- Proactively identify and manage quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies relative to project delivery.
- Ensures that project meets defined expectations and operational metrics through regular review and reporting.
- Bachelor's degree in a health care or other scientific discipline or educational equivalent; Clinical Project Management experience or strong Clinical Operations Manager experience.
- Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Strong operational understanding of interventional clinical trials and tactical clinical trial leadership skills. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. Strong written and verbal communication skills including good command of English.
- Advanced customer management and excellent organizational and problem solving skills.
- Effective time management skills and ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong financial acumen.
- Respiratory or infectious disease (large seasonal and / or vaccine preferred) therapeutic experience
Examples of relevant experience (not inclusive of all relevant indications):
Infectious Disease & Vaccines
- Hepatitis B/C
- Dry eye
Rare Disease (non oncological)
- Blood diseases
- Inborn errors of metabolism
- Cell and gene therapy
skills: Clinical research
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.