What are the responsibilities and job description for the Associate Director Clinical Research position at NS Pharma, Inc.?
Job Summary
Responsible for the management and execution of various aspects of clinical studies (implementation, site selection, patient recruitment, vendor oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements.
Essential Duties and Responsibilities
Include but not limited to the following. Other duties may be assigned)
- Plan, implement, manage and report for regional or global clinical studies.
- Manage and Lead selection process of CROs for regional or global clinical studies.
- Manage the performance of study vendors (e.g. CROs and central labs).
- Manage and coordinate with the Clinical Lead to achieve project objectives.
- Manage and resolve project performance issues (issue management) if they arise.
- Manage activities for clinical site selection, investigator meetings and study initiation.
- Manage, provide guidance and direction to Sr. Managers.
- Oversight of patient recruitment and development of recruitment strategies and plans.
- Responsible 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.
- Oversight of data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan.
- Responsible 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
- Create and maintain 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.
Supervisory Responsibility
Supervise two (2) Sr. Managers in Clinical Research. Responsible for their performance management including professional development.
Qualifications
Education & / or Experience
