Manager, Scientific Affairs

Diagnostica Stago • Parsippany, NJ

10h • Onsite

About The Position

The Manager, Scientific Affairs will supervise staff in the completion of tasks, develop their skills through training, and develop new employees. This role ensures clinical studies are designed to validate products' intended use and meet U.S. regulatory requirements, while also ensuring compliance with current Good Clinical Practice (cGCP). The position oversees site selection, contracting, budgeting, and IRB submissions for all studies. Responsibilities include supervising and coordinating efforts for trials both internally and through vendors, acting as the primary contact between CRO/sponsor and investigational sites, and reviewing/approving various study documents. The role involves conducting data reviews, preparing summaries for regulatory submissions, and strategizing responses to regulatory agencies. Collaboration with internal departments like Supply Chain, Field Support, Training, Marketing, Quality, and Legal is crucial for developing SOPs and clinical strategy. The Manager is responsible for the Study Master File (SMF), developing and implementing metrics for optimal CRA performance, and managing staff adherence to timelines. They will hold formal check-ins with the Director of Market Access, prepare reports, and manage the Scientific Affairs Budget. Partnering with external organizations to maintain industry understanding and providing on-site support for clinical trials are also key aspects. Continuous learning regarding regulatory requirements and clinical practice is essential.

Requirements

• A Bachelor's degree in a relevant health-related field or scientific discipline, such as biology, chemistry, or biotechnology required.
• 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).
• Valid driver's license and ability to travel internationally is required.
• This job requires the individual to be fully vaccinated against COVID-19, absent a legally required accommodation, as determined by customer requirements.

Nice To Haves

• A Masters degree is preferred.
• Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable.
• Coagulation/Hematology experience preferred.

Responsibilities

• Supervise staff in the completion of tasks.
• Develop staff 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.
• Review 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 DSA and DSI Supply Chain, Field Support, Training, Marketing, Quality and Legal to strengthen relationships and mutual trust.
• Develop and review clinical SOPs.
• Develop clinical strategy for innovative technologies projects and/or products.
• 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.
• 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.

Benefits

• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager