Clinical Trial Project Manager

Job Description: Clinical Trial Project Manager

Company: Sygnola Research, LLC

Location: Primarily remote, with extensive travel to trial sites as needed and weekly to Sygnola headquarters

Employment Type: Full-Time

Overview

Sygnola Clinical Research Organization is a leading organization dedicated to advancing medical and scientific research through innovative clinical trials. We are committed to improving patient outcomes and fostering groundbreaking discoveries in healthcare. Our team is driven by a passion for excellence, collaboration, and integrity in all aspects of clinical research.

Position Summary

Sygnola Clinical Research Organization is seeking an experienced and highly organized Clinical Trial Project Manager to oversee the planning, execution, and completion of clinical trials. The Clinical Trial Project Manager will be responsible for managing all aspects of clinical trial projects, ensuring compliance with regulatory requirements, timelines, and budgets while maintaining the highest standards of quality. This role requires strong leadership, communication, and problem-solving skills to coordinate cross-functional teams and deliver successful trial outcomes.

Key Responsibilities

• Project Planning and Execution:
• Develop and manage comprehensive project plans, including timelines, milestones, and resource allocation for clinical trials.
• Coordinate with internal teams (e.g., clinical operations, data management, regulatory affairs) and external stakeholders (e.g., CROs, sponsors, and investigators) to ensure seamless trial execution.
• Monitor project progress and implement corrective actions to address risks, delays, or deviations from the project plan.

• Regulatory Compliance:
• Ensure all clinical trials comply with applicable regulations, including FDA, ICH-GCP, and other global regulatory standards.
• Oversee the preparation and submission of regulatory documents, including protocols, informed consent forms, and investigator brochures.
• Maintain accurate and up-to-date documentation for audits and regulatory inspections.

• Budget and Resource Management:
• Develop and manage trial budgets, ensuring cost-effectiveness and adherence to financial constraints.
• Allocate resources efficiently, including personnel, equipment, and vendors, to meet project goals.
• Negotiate contracts with vendors, CROs, and other service providers to secure favorable terms.

• Team Leadership and Collaboration:
• Lead cross-functional project teams, fostering a collaborative and results-driven environment.
• Provide clear direction, mentorship, and support to team members to ensure alignment with project objectives.
• Facilitate effective communication between internal teams, external partners, and stakeholders.

• Risk Management and Quality Assurance:
• Identify potential risks to trial success and implement mitigation strategies proactively.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and quality standards throughout the trial lifecycle.
• Conduct regular quality checks and audits to maintain data integrity and trial compliance.

• Stakeholder Engagement:
• Serve as the primary point of contact for sponsors, investigators, and other key stakeholders.
• Provide regular updates on trial progress, challenges, and outcomes through reports and presentations.
• Build and maintain strong relationships with clinical sites, vendors, and partners to support trial success.

• Data and Reporting:
• Oversee data collection, management, and analysis processes to ensure accuracy and compliance with protocols.
• Prepare and deliver detailed reports on trial status, including enrollment, adverse events, and key performance indicators.
• Contribute to the development of clinical study reports and publications.

Qualifications

• Education:
• Bachelor’s degree in life sciences, healthcare, or a related field (advanced degree, Master’s preferred).

• Experience:
• Minimum of 5 years of experience in clinical trial management, with at least 3 years in a project management role.
• Proven track record of successfully managing complex clinical trials from initiation to closeout.
• Experience working with CROs, vendors, and clinical sites in a global or multi-site setting.

• Skills and Competencies:
• Strong knowledge of clinical trial processes, regulatory requirements, and GCP guidelines.
• Exceptional organizational and time-management skills, with the ability to manage multiple projects simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse stakeholders.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, or similar) and clinical trial management systems (CTMS).
• Analytical mindset with strong problem-solving and decision-making abilities.
• Ability to work independently and lead teams in a fast-paced, dynamic environment.

• Certifications (preferred):
• Project Management Professional (PMP) certification or equivalent.
• Certified Clinical Research Professional (CCRP) or similar certification.

Work Environment

• This position may require occasional travel to clinical sites (up to 20% travel), regular weekly travel to Sygnola headquarters for CRO meetings.
• Flexible work arrangements, including hybrid or remote options, may be available depending on project needs and company policies.
• The role involves working in a fast-paced environment with tight deadlines and high expectations for quality and accuracy.

Compensation and Benefits

• Competitive salary commensurate with experience.
• Comprehensive benefits package, including health, dental, and vision insurance, retirement plans, and paid time off.
• Opportunities for professional development and career advancement within a growing organization.

Physical Requirements

• Ability to travel frequently, including overnight stays, via air, rail, or car.
• Capability to carry training materials and equipment during site visits.

How to Apply: Interested candidates should submit a resume and cover letter outlining their qualifications and experience.

Why Join Sygnola Clinical Research Organization?

At Sygnola, we are committed to advancing medical research through innovative clinical trials. As a Clinical Trial Project Manager, you will play a pivotal role in ensuring the success of our trials, collaborating with top-tier research sites, and contributing to groundbreaking healthcare solutions. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth.

Sygnola Clinical Research Organization is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.