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The job details are as follows:Work independently to ensure the success of a local or regional clinical trial. Provide oversight and coordination for the operational delivery of ongoing local or regional clinical trials to ensure all required timelines are met as well as adherence to budget, quality, and performance expectations.
- Utilize advanced expertise and serve as the primary study contact for study-related communication, coordinating with teams, management, and vendors
- Independently oversee the entire lifecycle of clinical trials, from start-up to close-out
- Direct local or regional clinical trials, ensuring cross-functional activities align with study objectives
- Administer study budgets and timelines, maintaining high-quality standards and performance metrics
- Identify, resolve, or escalate any concerns regarding study timelines and deliverables promptly
- Proactively escalate performance related concerns with appropriate line management
- Manage protocol deviations/violations diligently, reducing their occurrence through proactive collaboration
- Collaborate with Clinical Operations to monitor key performance indicators, enhancing study efficiency
- Provide consistent updates on study progress to the project team and management
- Manage insourcing / outsourcing partners, ensuring compliance with standards and expectations
- Contribute to the development of study concepts, protocols, and critical study documents
- Engage in the creation of policies, guidelines, and SOPs, contributing to the advancement of Clinical Operations and Study Management
- Assess and enhance current processes, recommending improvements to management
- Ensure study conduct aligns with SOPs, ICH/GCP guidelines, and local regulations
- Manage vendor relationships, including selection, negotiation, implementation, and statement of work (SOW) oversight
- Ensure comprehensive protocol and process training for all study team members
- Manage resources allocated to the study, excluding staff management
- Review and endorse team member transition plans as necessary
- Assist in the preparation of interim and primary analysis reports
- Organize and oversee Investigator Meetings, ensuring effective coordination
- Perform all other duties as required
Education and Experience requirements for Clinical Project Manager II level:
- Bachelor's degree in related field and 8+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development
- Master's degree in related field and 6+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development
Education and Experience requirements for Senior Clinical Project Manager level:
- Bachelor's degree in related field and 10+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development
- Master's degree in related field and 8+ years of related clinical study management or project management experience in CRO/pharmaceutical operations and development
- Ability to interact and communicate effectively, both verbally and in writing, within and outside clinical operations, with colleagues, upper management, Key Opinion Leaders, vendor personnel, and clinical investigators and site personnel
- Strong working knowledge of GCP/ICH regulations and guidelines
- Strong overall scientific and clinical/medical research background
- Experience and comfort in working both independently and as part of a cross-functional team
- Proficiency with MS Office Suite including Word, Excel, PowerPoint, and Outlook
- Experience with EDC and CTMS systems
- Commitment and ability to handle high workloads, demanding situations, and deadlines
- Ability to proactively identify potential issues and formulate potential course(s) of action
Preferred Qualifications
- Master's degree
- 3+ years of related experience as a CRA, Clinical Manager, and/or Project Manager in the biopharmaceutical industry highly preferred
- RN - Registered Nurse - State Licensure and/or Compact State Licensure
- Previous experience with all phases of clinical research
- Demonstrated leadership experience as evidenced by the ability to motivate teams, provide advanced planning analysis, provide strategic guidance by evaluating risks against departmental deliverables
Job Location & Travel
This position will be located at our Durham, NC office with a hybrid schedule of 4 days in office and the option to work 1 day each week from home. In office requirements could change based on business needs. This position may travel up to 30%.
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
