Clinical Research Manager

Under the direction of the Sr. Project Manager, the Project Manager, manages all aspects of assigned clinical trials involving patient and normal healthy subject populations in both inpatient and outpatient settings. This position acts as the liaison between the sponsor and the research team. It assures sponsor requirements and specifications are communicated to the teams on a timely basis and that any issues raised by the teams are communicated back to the sponsor so they can be resolved in a timely and appropriate manner.Under the direction of the Sr. Project Manager, the Project Manager, manages all aspects of assigned clinical trials involving patient and normal healthy subject populations in both inpatient and outpatient settings. This position acts as the liaison between the sponsor and the research team. It assures sponsor requirements and specifications are communicated to the teams on a timely basis and that any issues raised by the teams are communicated back to the sponsor so they can be resolved in a timely and appropriate manner.Education: • Bachelors degree, or licensure in a health profession (i.e. RN, LVN), or an equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills and abilities.• Minimum of 3 years experience in clinical research, program management, clinical auditing, or QA/Regulatory Affairs and a minimum of 1 year clinical project management experience or experience handling multiple or global projects in another area of clinical research Knowledge, Skills and Abilities: · Basic computer skills with working knowledge of Microsoft Office software· Effective time management skills· Strong leadership and team-building skills· Excellent written and verbal communication skills· Ability to prioritize the elements of each unique study plan and to alter the elements on a continuous basis according to study progress· Ability to effectively handle multiple tasks and priorities in a professional manner, assuring sponsor satisfaction and staff cooperation· Effective planning skills for the accomplishment of both short and long term goals for each study.· Ability to analyze and interpret study financial statements and contractual agreements with sponsors and subcontractors· In depth knowledge of the clinical research process (i.e. Good Clinical Practices, obtaining informed consent, drug dispensation and accountability, process for handling protocol amendments, obtaining ethical reviews and providing ongoing reports to IRBs) PPD is an equal opportunity employer, M/F/D/V – embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service. Education: • Bachelors degree, or licensure in a health profession (i.e. RN, LVN), or an equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills and abilities.• Minimum of 3 years experience in clinical research, program management, clinical auditing, or QA/Regulatory Affairs and a minimum of 1 year clinical project management experience or experience handling multiple or global projects in another area of clinical research Knowledge, Skills and Abilities: · Basic computer skills with working knowledge of Microsoft Office software· Effective time management skills· Strong leadership and team-building skills· Excellent written and verbal communication skills· Ability to prioritize the elements of each unique study plan and to alter the elements on a continuous basis according to study progress· Ability to effectively handle multiple tasks and priorities in a professional manner, assuring sponsor satisfaction and staff cooperation· Effective planning skills for the accomplishment of both short and long term goals for each study.· Ability to analyze and interpret study financial statements and contractual agreements with sponsors and subcontractors· In depth knowledge of the clinical research process (i.e. Good Clinical Practices, obtaining informed consent, drug dispensation and accountability, process for handling protocol amendments, obtaining ethical reviews and providing ongoing reports to IRBs) PPD is an equal opportunity employer, M/F/D/V – embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.