Website Berman Larson Kane
Best Staffing Since 1980
Manager, Scientific Affairs
Job Category: Medical affairs & regulatory registrations
- Full-Time / Hybrid/Parsippany, NJ
Job Details Description
Essential Duties & Responsibilities:
- Supervise staff in the completion of tasks. Develop their skills through training. Develop new employees. Maintain staff by recruiting.
- Ensure clinical studies are designed to validate the products intended use and meet U.S. regulatory requirements. .
- Ensure clinical studies are conducted in compliance with current Good Clinical Practice (cGCP).
- Oversee site selection, contracting, budgeting and submission to the IRB for all studies
- Supervise and coordinate efforts for trials both within the organization and through a variety of vendors (Clinical Sites, Reference Labs, CROs etc.) as applicable
- Act as the primary contact between the CRO/sponsor and investigational sites (labs/clinics).
- Review and Approve
- design validation plans
- clinical study protocols, monitoring plans/reports
- site monitoring plan/report
- site visit reports and other study documents.
- site protocol deviations, adverse events forms, notes to file
- and other required documents for clinical studies.
- Conduct data reviews and prepare data summaries that support development of the clinical sections of U.S. regulatory submissions. Provide these summaries to the Regulatory Affairs team. Help to strategize and/or coordinate responses to regulatory agencies\ questions regarding the clinical study.
- Directly and effectively partner and collaborate with Supply Chain, Field Support, Training, Marketing, Quality and Legal
- to strengthen relationships and mutual trust
- to develop and review clinical SOPs.
- to develop clinical strategy for innovative technologies projects and/or products
- to develop and review site contracts and budgets
- Responsible for the Study Master File (SMF) and assure that all necessary documents are present, completed and signed before study close-out.
- Develop and implement metrics, policies, procedures, and protocols to ensure optimal CRA performance in line with cGCP and Good Documentation Practices (cGDP).
- Develop, with Director of Market Access, key metrics for staff to ensure project timeliness and manage staff adherence to timelines.
- Hold formal check-ins with Director of Market Access summarizing:
- Status of all active studies and projects
- Contracts / IRB / site statuses
- Timelines vs. plan
- Risks, mitigation actions, and resource needs
- materials needed
- Prepare and present reports to Director of Market Access, highlighting laboratory and CRA performance, achievements, and challenges, and making recommendations for improvement.
- Manage the Scientific Affairs Budget based on the payments/expenses of each individual study budget
- Partner and collaborate with external organizations to ensure a contemporary understanding of the industry along with technical requirements
- Occasionally, will be required to provide on-site support for clinical trial preparations, executions and monitoring responsibilities.
- Remain current with regulatory requirements, quality assurance and quality control programs via professional and educational opportunities.
- Continuous learning to advise the organization regarding important changes in clinical practice.
Education and/or Experience:
- A Bachelor’s degree in a relevant health-related field or scientific discipline, such as biology, chemistry, or biotechnology required. A Masters degree is preferred..
- Minimum of seven years clinical research related experience required.
- Minimum three years experience with clinical studies conducted per GCP with direct clinical site monitoring and/or clinical site management experience required..
- Strong background/Strong knowledge of clinical practice, safety protocols, and regulatory requirements is a must.
- Previous experience in a supervisory or managerial role, with a minimum of three years managing clinical study personnel is required.
- Knowledge of CLSI standards is a must.
- Proficient with MS Office suite of products.
- Familiarity with electronic clinical trial systems (CTMSs or EDCs).
- Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable. Valid driver’s license and ability to travel internationally is required.
- Coagulation/Hematology experience preferred.
- Up to 20% travel required, international travel required.