||Manage the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements.
|Essential Duties and
(Include but not limited to
Other duties may be assigned)
- Assist to plan, implement, manage and report for regional or global clinical studies.
- Manage selection process of CROs for regional or global clinical studies.
- Manage the performance of study vendors (e.g. CROs and central labs).
- Manage activities for clinical site selection, investigator meetings and study initiation.
- Oversight of patient recruitment and development of recruitment strategies and plans.
- Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.).
- Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans.
- Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols.
- Coordinate negotiation of clinical trial contracts between investigational sites and CROs.
- Manage data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan.
- Support for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites.
- Implement project specific training program and training materials.
- Support Creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes.
- Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.).
- As needed and required perform other tasks and functions.
- Must be able to manage and coordinate with the Clinical Lead to achieve project objectives and able to manage/solve project management performance issues if they arise.
- Demonstrated ability to support the development and management of various aspects of the end to end study operational plan.
- Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors.
- Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies.
- Ability to handle multiple tasks and prioritize.
- Strong organizational, communication and presentation skills.
- Team player, flexible, ability to adapt to change.
- Bachelor’s Degree in sciences or related field with a minimum of 5 years of pharmaceuticals/biotech experience.
- Minimum of 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials.
- Program and project management experience preferred.