Clinical data management Jobs in Detroit, MI

Job Description

We're looking for a detail-oriented and organized Research Project Management I professional to join our Clinical Trials Office in Detroit, United States. In this role, you will be the driving force behind coordinating and managing clinical research projects from initiation through successful completion. You will work collaboratively with cross-functional teams, regulatory agencies, research sites, and external vendors to ensure all clinical trials are executed with precision, in full compliance with regulatory requirements, and in alignment with organizational standards. The ideal candidate will demonstrate exceptional analytical skills, outstanding organizational abilities, and an unwavering commitment to maintaining the highest standards of accuracy and professionalism in a dynamic, fast-paced research environment.

• Coordinate and manage multiple clinical trial projects simultaneously, ensuring strict adherence to timelines, budgets, and regulatory requirements
• Develop, maintain, and organize comprehensive project documentation, including protocols, regulatory submissions, and compliance records with meticulous attention to detail
• Communicate effectively and transparently with internal stakeholders, external vendors, research sites, and regulatory agencies to facilitate seamless project progress
• Monitor project milestones and deliverables proactively, identifying potential risks early and implementing mitigation strategies to ensure successful trial execution
• Maintain detailed and accurate project records and databases, ensuring accessibility and integrity of all trial-related information
• Assist in the preparation and submission of regulatory documentation to appropriate authorities, ensuring compliance with all requirements
• Track and manage project budgets, resource allocation, and vendor contracts with analytical precision
• Conduct thorough quality assurance reviews to verify compliance with Good Clinical Practice (GCP) guidelines and organizational policies
• Coordinate site initiation visits, investigator meetings, and training sessions, demonstrating strong organizational and interpersonal skills
• Prepare and present comprehensive project status reports to management and stakeholders with clarity and transparency
• Support the Clinical Trials Office in maintaining regulatory compliance and audit readiness through diligent documentation and process adherence
• Prioritize competing deadlines and manage complex workflows while maintaining flexibility and resilience in a dynamic environment

Qualifications

**Required Qualifications:**

• 2-4 years of project management experience in clinical research, clinical trials, or a related healthcare research environment
• Strong knowledge of regulatory compliance requirements, including FDA regulations and ICH-GCP guidelines
• Demonstrated experience with protocol development, management, and implementation in clinical settings
• Excellent organizational and time management skills with proven ability to manage multiple projects simultaneously
• Proficiency in data management and documentation practices with a commitment to accuracy
• Strong written and verbal communication skills with ability to convey complex information clearly
• Ability to work collaboratively with diverse teams and stakeholders across organizational levels
• Exceptional attention to detail with a demonstrated commitment to accuracy and quality in all deliverables
• Problem-solving and risk mitigation skills with ability to identify and address challenges proactively
• Stakeholder management experience with ability to build and maintain professional relationships

**Preferred Qualifications:**

• Experience with Clinical Trial Management Systems (CTMS) or similar project management software
• Familiarity with regulatory submission processes and documentation requirements
• Experience coordinating with research sites and managing vendor relationships effectively
• Knowledge of quality assurance and audit procedures in clinical research environments
• Experience with budget tracking and financial management in research settings
• Certification in project management or clinical research (such as ACRP or SOCRA)
• Experience with compliance audit readiness and regulatory inspection preparation
• Familiarity with electronic data capture (EDC) systems and clinical trial technology platforms