The Project Manager is responsible for the independent oversight of clinical trial activities of multiple assigned projects in the oncology indication from protocol development through production of the final report. The Project Manager is also responsible forproviding guidance to Project Team Leaders and ensuring assigned projects are completed according to timelines, Novum SOPs, Good Clinical Practices, and applicable regulations.
Work with the Site Identificaiton Department to develop a network of Oncology Investigator sites.
Work on the feasibility process and assist in determining the Investigator site budgets.
Develop the stragey for conducting Oncology studies at Novum in a cost efficient manner.
Provide indication specific training for the Oncology study team.
Manage assigned projects from the development of the protocol through production of the final report including but not limited to the following:
Identify and select Investigator Sites.
Negotiate Investigator agreements and ensure timely payments to Investigator Sites.
Manage projects to ensure timelines and budget are met.
Train team members on assigned study.
Collaborate with statisticians, medical personnel and Scientific Affairs to produce final study report, including writing text as needed.
Review monitoring reports and supervise monitoring staff assigned to project.
Communicate study status to senior management and sponsors.
Assist senior management on departmental projects.
Participate in bid defense or study award meetings with sponsors.
Provide input on performance evaluations for monitoring staff to Clinical Lead and Clinical Trials Staff Manager.
Manage specialized studies such as Phase I projects complex studies.
Other Duties as assigned.
Novum Pharmaceutical Research Services is an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Bachelor’s Degree from a four-year college or university and/or training or equivalent combination of 7 years or more in clinical research including Oncology and 3 years in project management.
Experience Managing Global Clinical Trials at least 2 years and in Europe.
Ability to travel 50% that will be irregular in nature and may include international travel.
Valid Driver's License
About Novum Pharmaceutical Research Services
Novum is a full-service CRO with numerous FDA approvals in ANDA and NDA submissions. We conduct more than 250 studies a year across multiple therapeutic areas and have developed long-standing relationships with a wide range of global sponsors who rely on our Early Phase Research and Clinical Trial Management expertise.