Senior Associate Study Manager

As a Senior Associate Study Manager, you will play a key role in improving the lives of patients by accelerating the development of our customers ' drugs and devices through innovative solutions.

KNOWLEDGE

• Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), FDA regulations and guidelines, and applicable international regulations and guidelines
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Experience with development of prospective site –selection criteria
• Understanding drug development process and procedures
• Good organization, planning & communication skills
• Project planning experience including oversight of study deliverables, budgets, and timelines
• Ability to use scientific and clinical knowledge to conceptualize study designs
• Experience anticipating and resolving problems
• Experience writing and presenting clearly on scientific and clinical issues
• Experience collaborating and leading cross-functional teams (team/matrix environment)
• BS Degree or RN with relevant clinical trial experience
  Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level

• Work with the clinical trial management staff to support the execution and monitoring of clinical studies and trial deliverables.
• Participate in study planning and set-up activities including vendor management, project management, and coordination of study and implementation plans.
• Contribute to and support with the preparation, writing and review of study related documents including but not limited to, clinical protocols, consent forms, study guides, monitoring plans, e(CRF)s, subject information sheets, clinical study report, regulatory submissions and publications.
• Quality Check study protocols and ICFs
• Coordinate the activities associated with site start-up and overall trial management
• Assist in identification and evaluation of clinical trial investigators and Phase 1 clinical research units.
• Author monitoring plan, IPD list, IPIM
• Contribute to the study level forecast of IP and support the creation of DSP and JCP
• Provide input into the development of CRFs and SAP
• Contribute to, or coordinate preparation and conduct of site initiations, monitors workshops (as applicable) and investigator meetings (as applicable)
• Assists in preparing and managing Study Budgets and timelines
• Coordinate study level investigational product arrangements and study start-up and management activities.
• Serve as one of the first points of contact within Early Development for study-related issues
• Support vendor relationships
• Perform protocol-related site management activities
• Assists for ensuring all site and study team members are trained on the conduct of the study and they understand the study timelines and deliverables. Coordinate activities as needed between study team members.