This position will require strong scientific writing skills and leadership to drive the development of a phase 3 Acute Myeloid Leukemia registration trial.
Strong collaboration with cross functional team members.
Scheduling and facilitating protocol review meetings.
Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
Participate in ad hoc meetings.
Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
Oversee and challenges the adequacy of planning for study implementation.
In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals.
Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.
Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety).
Collaborates and supports operational activities as need be.
Assist in establishing project budgets.
Assist with review of ongoing summary hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
Work directly into the clinical database to post and resolve queries with the sites.
Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent.
Protocol writing experience is REQUIRED.
Minimum 2 yrs experience in oncology/hematology clinical development.
Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
Experience with electronic data bases (EDC, RAVE, JReview etc)
Knowledge of clinical trial design, basic statistics, and data review tools
Proficient at data interpretation.
Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions.
Full understanding GCP and ICH Guidelines.
Ability to assimilate technical and scientific information quickly.
Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus).
Demonstrated ability to work as part of a team