Associate Clinical Research Manager, Immunology

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

📋 Description

• Oversee the complete performance and project management for assigned clinical research protocols within a specific country or cluster.

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

• Strategize, manage, and monitor study deliverables, timelines, and outcomes from feasibility and site selection through recruitment, execution, and closeout.

• Ensure adherence to ICH-GCP, local regulations, company policies, quality standards, and adverse event reporting obligations.

• Evaluate Monitoring Visit Reports, raising any performance issues and training needs.

• Conduct quality control visits as necessary.

• Lead local study teams, provide training on protocols for local roles, support CRAs as a protocol expert, and coordinate activities within the country.

• Develop and implement local risk management plans.

• Guarantee compliance with CTMS, eTMF, and other critical systems.

• Report challenges and issues to the relevant clinical and quality leadership.

• Identify and disseminate best practices.

• Work collaboratively with outsourcing vendors, investigators, and external partners.

• Cultivate business relationships with investigators and represent the company effectively.

• Assist in the development of local and regional strategies.

• Collaborate with headquarters, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, and Global Medical and Scientific Affairs.

• Travel up to 30% of working time (the posting also indicates a 25% travel requirement).

⛳️ Requirements

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

• A minimum of 4 years’ experience in clinical research.

• Familiarity with project management and/or site management.

• Exceptional organizational skills.

• Capability to make independent decisions and oversee clinical research activities.

• Comprehension of the local regulatory landscape.

• Knowledge of scientific and clinical research principles.

• Awareness of clinical trial planning, management, and metrics.

• Ability to handle multiple deliverables and protocols at once.

• Proficiency in linking Country Operations with Clinical Trial Teams.

• Strong written and verbal communication skills in English and the local language.

• Competence in project, process, productivity, quality, and delivery management.

• Strategic thinking and adept problem-solving abilities.

• Negotiation and conflict-resolution capabilities.

• Awareness of cultural differences.

• Strong diplomatic and empathetic skills.

• No visa sponsorship available.

• No relocation assistance offered.

• A valid driving license is not required.

🏝️ Benefits

• Eligibility for an annual bonus.

• Long-term incentive eligibility, if applicable.

• Comprehensive medical, dental, and vision healthcare coverage.

• Additional insurance benefits for employees and their families.

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

• Paid holidays.

• Vacation days.

• Compassionate leave and sick days.

• Flexible remote work arrangements.