Strength Through Diversity
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Dept- Tisch 015 REQ #2569092
Job Title: Project Manager I
- Under the leadership of the PI in the Multiple Myeloma division of the Tisch Cancer Institute, the Project Manager I will ensure the effective and efficient delivery of all operational aspects of one or more clinical studies, in accordance with the appropriate quality standards including ICH/GCP and applicable global regulations.
- The candidate must possess excellent interpersonal and communication skills, as the position may involve extensive interaction with patients, physicians, researchers, clinical staff and collaboration with multiple departments. He/she should be capable of performing both independently and as part of a team, demonstrating the ability to multi-task and take initiative. Strong organizational skills and attention to detail are essential. The position also requires training in Institutional Review Board (IRB) protocols, HIPAA and human subject research.
- Assisting with oncology clinical research projects in the Tisch Cancer Center including clinical documentation development for regulatory submissions, clinical trial management and publications
- Responsible for clinical trials/research and management, documentation management and control including preparation & maintenance of IRB paperwork, and working with the clinical research team and physicians
- Working with patients for scheduling, compliance to protocols, and patient outcomes and adverse events follow up, as needed
- Ensures that the clinical and laboratory procedures are conducted as per clinical trial protocols
- Organizing and maintaining patient folders, collecting patient follow up information and providing electronic data capture
- Oversee clinical trial data integrity and maintain datasets
- Applying same responsibilities to other ongoing clinical research & trials in Oncology
- Tracks and manages clinical research activities and prepares status reports and liaises with clinical personnel to ensure that the study data are available for clinical review in prep for patient care and treatment
- Participates in Tumor Management Committees/ Data Review Teams and Data Safety Management Boards
- Collaborates with external partnerships as part of the overall clinical study team
- Ensures adherence to Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, data protection guidelines, HIPPA and study procedures, as applicable.
- Primary Liaison between the various project teams, mainly the Multiple Myeloma Team and the Translational Team
- Other related duties.
- BA/BS degree in Life Sciences discipline required; Master’s degree or greater preferred, or equivalent combination of experience and education.
- 6+ or more years of relevant project and/or clinical trial management experience required.
- Previous experience with oncological research will be beneficial.
- A suitable candidate should have some experience with clinical research.
- Proven clinical development experience, including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
- Experience with the preparation of reports and/or presentations/communications via tools such as PowerPoint.