Clinical Research Manager – Infectious Disease/Vaccine

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee comprehensive performance and project management for designated clinical trial protocols within a specific country or cluster of countries.

• Act as the primary liaison between Country Operations and Clinical Trial Teams.

• Strategically plan, manage, and monitor study deliverables, timelines, and outcomes from feasibility and site selection through to recruitment, execution, and closure.

• Evaluate Monitoring Visit Reports and address performance concerns and training requirements.

• Conduct quality control visits as necessary.

• Lead local study teams and provide training on protocols to local roles.

• Collaborate with and offer support to CRAs as a protocol authority.

• Coordinate tasks among local country roles, including CTCs, CRAs, and COMs.

• Develop and implement local risk management plans.

• Ensure adherence to CTMS, eTMF, and other critical systems.

• Report challenges and issues to the appropriate clinical and operational leadership.

• Discover and disseminate best practices across trials, countries, and clusters.

• Work alongside outsourcing vendors, investigators, and external partners.

• Serve as the country point of contact for programmatically outsourced trials.

• Cultivate business relationships with investigators and represent the organization.

• Assist in the development of local and regional strategies.

• Collaborate with headquarters, regional and local operations, clinical development, pharmacovigilance, and global medical affairs functions.

• Travel up to 30% of your working time.

⛳️ Requirements

• Minimum of 5 years of experience in clinical research.

• Bachelor's degree in a scientific discipline or a related field.

• Familiarity with project management and site management principles.

• Excellent organizational skills.

• Capacity to make independent decisions and oversee clinical research initiatives.

• Strong grasp of the local regulatory landscape.

• In-depth scientific and clinical research knowledge.

• Understanding of clinical trial planning, management, and performance metrics.

• Ability to juggle multiple deliverables and protocols concurrently.

• Experience in connecting Country Operations with Clinical Trial Teams.

• Proficient in both written and spoken English as well as the local language.

• Exceptional written and verbal communication capabilities.

• Ability to think strategically.

• Competence in working effectively in a remote and virtual environment.

• Awareness of cultural inclusivity.

• Demonstrated strong project management skills and/or certification in project management or relevant training programs/mentorship.

• Strong leadership, conflict resolution, negotiation, diplomacy, empathy, and stakeholder relationship skills.

• CRA experience is preferred.

• Experience in Infectious Disease/Vaccine research is preferred.

• Prior trial management experience is preferred.

• No visa sponsorship is available.

• Regular employee status.

🏝️ Benefits

• Eligibility for annual bonuses.

• Long-term incentive eligibility, if applicable.

• Comprehensive medical, dental, and vision healthcare plans.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation days.

• Compassionate leave.

• Sick leave.

• Flexible remote work arrangements.