Sr Manager, Global Clinical Science Neuroscience Princeton NJ
Job Location:
Princeton, NJ - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
The Senior Manager Global Clinical Science function provides scientific expertise necessary to design and deliver clinical studies and programs.
Position Summary / Objective
Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
May serve as Clinical Trial Lead for one or more trials
May lead or support trial level activities for one or more trials with the necessary supervision
May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
Position Responsibilities
Collaborate and liaise with external partners (e.g. KOLs)
Seek out and enact best practices with instruction
Provide regular and timely updates to manager/management as requested
Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
Conduct literature review
Submit clinical documents to TMF
Develop site and CRA training materials and present these at SIVs and Investigator meetings
Review clinical narratives
Monitor clinical data for specific trends
Develop Data Review Plan in collaboration with Data Management
Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g. IB DSUR PSUR Orphan Annual Reports HA EC IRB responses and contribute to regulatory submission.)
Degree Requirements
Degree in Life Sciences (MD PhD Pharm D MS RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)
Experience Requirements
Basic knowledge of GCP/ICH drug development process study design statistics clinical operations
Ability to understand assigned protocol(s) and their requirements
Basic knowledge skills to support program-specific data review and trend identification
Intermediate medical writing skills and medical terminology
Basic planning/project management skills (develop short range plans that are realistic and effective)
Key Competency Requirements
Detail-oriented with commitment to quality
Basic knowledge of disease area compound current clinical landscape
Basic knowledge of the establishment and operation of data monitoring committees dose review teams and independent response adjudication committees
Intermediate critical thinking and problem-solving skills
Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g. Pt Profiles report generating tools)
Travel Required
Domestic and International travel may be required.
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
Cambridge Crossing: $173390 - $210110
Madison - Giralda - NJ - US: $150770 - $182701
Princeton - NJ - US: $150770 - $182701
Required Experience:
Manager
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
