**Must have CRO and/or Sponsor Clinical Project Management experience**
Working within the Clinical Operations Department and the Project Management functional unit, the Clinical Project Manager is responsible for planning and executing the operational aspects of clinical research, while working closely with various individuals and departments internally and externally. This position is the primary point-of-contact and liaison with the Sponsor. The Project Manager will oversee the conduct of clinical trials in compliance with applicable FDA and ICH/GCP guidelines, global regulations, and Trial Runners Standard Operating Procedures.
Act as a liaison with the sponsor to oversee clinical studies to include:
Ensure study remains within the scope and out of scope activities are identified and handled as appropriate
Perform risk management and contingency planning activities to ensure that all potential study risks, such as delays in study milestones and increased study costs, are managed in a proactive and efficient manner
Facilitate team coordination and workflow for projects
Develop and Monitor project timelines and resources allocated
Communicate up-to-date information regarding project progress to all relevant interested parties
Provide strategic input on enrollment and contingency planning
Vendor management to include procurement and negotiation of contracts
Lead project team meetings to ensure on-time deliverables
Assist in protocol development and CRF design
Track departmental carbon footprint and implement policies, procedures, and practices to decrease the negative impact on the environment
Ensure all departmental purchases and practices reflect the company’s corporate citizenship policy
May manage clinical study budget and contracts
Knowledge of FDA and International Conference of Harmonization and Good Clinical Practices (ICH/GCP) Guidelines
Excellent written and verbal communication skills and detail-oriented skills
Various computer skills – Excel, Word, PowerPoint, Microsoft Outlook
Extensive understanding of principles, concepts, practices, and standards of clinical research
Excellent leadership skills
Excellent organizational skills, including the ability to handle multiple assignments
Possess full working knowledge of all required clinical study tasks and elements from study initiation through completion
Ability to ensure a good customer relationship is established and maintained
Bachelors Degree in science/health related field required
4-6 years of clinical experience in the pharmaceutical/CRO industry Required
Telecommuting is allowed.
Additional Salary Information: Additional Benefits: Up to 4%Bonus Opportunity. 2-weeks of vacation, 1-week personal time, and 10 paid company holidays including employee birthday. BC/BS Health Care Insurance: Low-deductible plan offered at the following employer contributions of 100% paid coverage for employee, 86% paid coverage for single plus dependent, 80.7% coverage for the family. Vision Insurance: 100% paid coverage for employee and family. Dental Insurance: 100% paid coverage for employee and 75% coverage for the family.
Trial Runners is an Ophthalmology CRO providing biotech and pharmaceutical companies with clinical research management services.