Clinical Research Manager

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

📋 Description

• Act as the primary liaison for designated protocols, connecting Country Operations with the clinical trial team.

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

• Ensure compliance of assigned protocols with ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting requirements.

• Review Monitoring Visit Reports and escalate any performance issues and training requirements.

• Conduct Quality Control visits as necessary.

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

• Develop and implement local risk management plans.

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

• Escalate challenges and issues to the relevant clinical research and quality leadership.

• Collaborate with outsourcing vendors, investigators, and external partners.

• Serve as the country contact for programmatically outsourced trials.

• Assist with local business needs, including contract signing and budget management when assigned.

• Work closely with headquarters, Pharmacovigilance, Regulatory, and Global Medical Affairs functions.

• Establish business relationships with investigators and represent the company in a customer-facing capacity.

• Share protocol-specific information and best practices among countries and clusters.

• Oversee comprehensive performance and project management for assigned clinical research protocols.

⛳️ Requirements

• Minimum of 5 years of experience in clinical research.

• Bachelor’s degree in a scientific field or an equivalent qualification.

• Proficiency in project management and site management.

• Excellent organizational skills.

• Capacity to make independent decisions and supervise clinical research activities in line with global policies.

• Strong understanding of the local regulatory landscape.

• Comprehensive knowledge of scientific and clinical research.

• Familiarity with clinical trial planning, management, and metrics.

• Ability to handle multiple deliverables and protocols at once.

• Proficient in written and spoken English, along with local language proficiency.

• Capability to manage resource allocation, processes, productivity, quality, and project delivery.

• Strategic mindset.

• Strong leadership abilities.

• Proficient in identifying problems, conflicts, and opportunities and preparing mitigation strategies.

• Skilled in negotiation and conflict resolution.

• Possess educational, diplomatic, and empathetic skills to maintain professional relationships.

• Knowledgeable in Clinical Quality Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, ICH GCP Guidelines, Regulatory Compliance, Risk Management, Strategic Planning, Team Leadership, and Training and Development.

• No visa sponsorship is offered.

• A valid driving license is not a requirement.

🏝️ Benefits

• Eligibility for annual bonuses.

• Long-term incentive eligibility, if applicable.

• Medical, dental, and vision healthcare coverage.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including 401(k) plans.

• Paid holidays.

• Vacation days.

• Compassionate leave and sick days.

• Opportunity for remote work arrangements.

• 25% travel requirement.

• No relocation is necessary.