Company: Confidential
Job Title: Associate Clinical Trial Manager
Job Number: 35509
Location: ,
Job Description
The Associate Clinical Trial Manager leads a team to oversee the successful execution of a clinical study, ensuring accuracy, quality, and compliance with regulatory requirements and protocol designs. Collaborating with cross-functional teams, this role ensures timely delivery of study milestones through effective planning, organization, and tracking of the clinical monitoring process, administration of clinical trials, site staff training, study closeout activities, and other necessary tasks.
Responsibilities
- Manage CRA team deliverables and mentor team on roles and study protocols.
- Oversee study monitoring adherence to SOPs, GCP guidelines, regulations, and risk-based quality standards.
- Monitor site trends and metrics, guiding risk assessments and quality improvements.
- Contribute to the development of study documents and process optimization.
- Manage relationships with clinical sites and resolve escalated issues.
- Coordinate site monitoring, training, visit schedules, and reporting.
- Develop and implement CRA training plans, tracking metrics and reports.
- Support co-monitoring visits and ensure CRA deliverables are met.
- Assist with Investigator/Site identification and meetings.
- Create monitoring plans, reports, and playbooks for team use.
- Develop site trainings and presentations for SEV, SIV, and others.
- Support site audits and inspections, following up on findings.
- Collaborate on tools and processes for Quality Evaluation visits.
- Ensure compliance with regulations and company policies.
- Contribute positively to the team and take on additional tasks as needed.
Required Skills
Qualifications and Requirements:
- Bachelor's or Master's degree in a science-related field.
- Over 4 years of clinical research experience, including project management or equivalent education/training.
- Strong understanding of clinical study processes and ICH-GCP guidelines.
- Solid knowledge of clinical trial regulations (e.g., FDA, EMEA).
- Hands-on experience in managing and mentoring teams.
- Experience in biotech, pharmaceutical, or medical device industries preferred.
- Previous experience in related fields (e.g., internships, co-ops, fellowships) is a plus.
Skills and Competencies:
- Excellent interpersonal, problem-solving, and analytical skills.
- Ability to manage large and complex trials.
- Proven track record of effective cross-functional communication.
- Strong organizational skills and attention to detail.
- Demonstrated ability to lead fast-paced projects with urgency and efficiency.
- Experience translating technical concepts into clear documentation.
- Collaborative team player with an entrepreneurial mindset.
- High professionalism, ethical standards, and personal values.
Travel: Up to 30% travel may be required.
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