Job Title: Senior Manager, Clinical Research
Department: Clinical Research
Reports To: Director - Clinical Research
Status: Regular, Full-Time
Location: Paramus, NJ
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.
- 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 fulfillingt he 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.
- Supervise one (1) Manager in clinical operation.
- Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets.
- Good cross-functional team leader who fosters team spirit and team motivation (team work)
- Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors.
- Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies.
- Ability to anticipate and timely escalate issues and to define appropriate action plans
- Decision-making and problem-solving skills
- Ability to handle multiple tasks and prioritize
- Strong organizational, communication and presentation skills
- Team player, flexible, ability to adapt to change
Education and/or Experience
- 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.
- Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc.)
- Program and project management experience preferred.
Good Clinical Practice