Scientific Affairs Manager

SUMMARY

Seeking an experienced clinical research leader to oversee the planning, execution, and management of clinical studies supporting innovative diagnostic products. This position is responsible for ensuring studies are designed and conducted in compliance with regulatory requirements and current Good Clinical Practice (cGCP) standards. The role will provide leadership to clinical research personnel, manage study operations, collaborate with internal and external stakeholders, and contribute to regulatory submissions and strategic clinical initiatives.

RESPONSIBILITIES

• Lead, mentor, and develop clinical research staff through training, coaching, recruitment, and performance management.
• Ensure clinical studies are appropriately designed to support product validation and regulatory requirements.
• Oversee clinical trial activities to ensure compliance with cGCP, company procedures, and applicable regulations.
• Manage study start-up activities including site selection, contract negotiations, budgeting, and ethics committee submissions.
• Coordinate clinical research efforts with investigative sites, laboratories, contract research organizations (CROs), and other external partners.
• Serve as a primary liaison between sponsors, CROs, clinical sites, and other study stakeholders.
• Review and approve study-related documentation including:
• Clinical protocols
• Monitoring plans and reports
• Site visit documentation
• Validation plans
• Protocol deviations
• Adverse event reports
• Notes to file and other essential study records
• Analyze clinical data and prepare summaries to support regulatory submissions and responses to regulatory agency inquiries.
• Partner with cross-functional teams including Supply Chain, Quality, Training, Marketing, Legal, and Technical Support to support clinical initiatives and product development strategies.
• Assist in the development and revision of clinical standard operating procedures (SOPs).
• Support contract development, budget management, and clinical strategy planning for new products and technologies.
• Maintain complete and compliant study documentation and ensure all required records are finalized prior to study closure.
• Establish and monitor key performance metrics to drive operational excellence and ensure adherence to study timelines.
• Provide regular updates to leadership regarding study progress, milestones, risks, resource needs, and project status.
• Prepare reports summarizing study outcomes, team performance, and opportunities for process improvement.
• Manage clinical research budgets and study-related expenditures.
• Build and maintain relationships with industry organizations to remain informed of emerging trends and best practices.
• Provide occasional on-site support for clinical trial preparation, execution, and monitoring activities.
• Stay current on regulatory requirements, quality systems, and developments in clinical research and laboratory science.

QUALIFICATIONS

• Bachelor's degree in a scientific, biological, healthcare, or related discipline required. Master's degree preferred.
• Minimum of seven years of clinical research experience required.
• At least three years of experience conducting or managing clinical studies under Good Clinical Practice (GCP) guidelines.
• Minimum three years of supervisory or management experience leading clinical research personnel.
• Strong understanding of clinical research methodologies, regulatory requirements, and patient safety practices.
• Knowledge of Clinical and Laboratory Standards Institute (CLSI) guidelines required.
• Experience with clinical trial management systems (CTMS), electronic data capture (EDC) systems, and related technologies preferred.
• Proficiency with Microsoft Office applications.
• Professional certifications such as MT(ASCP) or CCRA are a plus.
• Experience within coagulation, hematology, diagnostics, laboratory sciences, or related healthcare fields preferred.
• Valid driver's license and ability to travel domestically and internationally.
• Ability to travel up to 20%.

WHAT'S IN IT FOR ME

• Opportunity to lead impactful clinical research programs supporting innovative healthcare technologies.
• High visibility role with significant influence on product development and regulatory strategy.
• Collaborative environment with cross-functional exposure across scientific, regulatory, quality, and commercial teams.
• Competitive compensation package with bonus potential.
• Comprehensive benefits package including medical, dental, vision, retirement savings plan, paid time off, life insurance, disability coverage, and leave programs.
• Opportunity for professional growth, leadership development, and continued learning within a dynamic and evolving industry.