Clinical Data Manager

MAPS PBC is seeking a motivated, enthusiastic Clinical Data Manager (CDM) to support the Data Management Team in the execution of Phase I-III clinical trials.  Reporting to the Director of Data Management & Services, the CDM will support data management activities covering study start-up, progression, and close-out within the Electronic Data Capture (EDC) system for projects conducted by MAPS PBC. The CDM will utilize knowledge of ICH-GCP standards, Title 21 CFR Part 11, and clinical trial processes, as well as proficiency in all aspects of data management from study start-up to study close-out. The ideal individual will have the ability to exercise good judgment in a variety of situations, with strong written and verbal communication, and organizational skills, and the ability to maintain a realistic balance among multiple priorities.

Location:

As we are primarily a virtual team, this is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required.  Applicants must be available 40 hours a week, during normal business hours for a California-based company. This position requires frequent phone and internet video meetings.

Hours:   Full-time, 40 hours per week. We are a West Coast-based company and applicants must be available during normal business hours

(9:00 AM - 6:00 PM Pacific Time, Monday through Friday). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement. 

Requirements:

• A Bachelor’s degree in a scientific or quantitative field
• 2+ years of experience in clinical data management
• Proficient in data management and database design concepts
• Working knowledge of ICH-GCP and FDA regulations
• Excellent organizational skills with great attention to detail
• Ability to work independently and collaboratively within a team
• Open and clear communicator
• Excellent written and verbal communication skills
• Ability to work proactively and effectively in a fast paced, high change environment
• Demonstrated initiative and resourcefulness
• Assumes responsibility and accountability for results
• Proficient computer skills including MS office products
• The qualified applicant must be flexible, well-organized, and can work well under pressure as well as prioritize

Responsibilities:

• Contribute to development of clinical trial database specifications, including electronic Case Report Form (eCRF) design, roles and permissions, query logic, edit check specifications, and data transfer specifications,
• Generate Data Management Plans, annotated eCRFs for biostatistician, source mappings, and eCRF instructions for end users using available templates
• Develop role-based test scripts and execution logs for User Acceptance Testing (UAT) of EDC systems 
• Conduct and document EDC issue analysis, investigation, and clean-up
• Generate data listings to facilitate central reviews needed for data clean-up, database reconciliation, data review, and discrepancy management
• Generate EDC screenshots for regulatory submissions, study measure license agreements, and issue reporting
• Review clinical research study protocols for database update implications
• Perform closeout activities including database freezes and locks to ensure archiving per applicable
• Develop EDC training materials
• File and track user training documentation and data management deliverables in electronic Trial Master File (eTMF)
• Maintain trackers for Issue Reporting, User Access Management, and User Roles and Permissions of EDC
• Assist with process development such as SOPs, work instructions, forms and templates for data management activities
• Record minutes during CDM meetings
• Report progress to appropriate project management, Clinical Operations, and Safety
• Communicate to internal and external clients (esp. regarding Data Management-led initiatives and issue reporting)
• Check in regularly with supervisor and complete assignments by agreed deadline
• Proactively seek methods of improvement, streamlining workflows, and building efficiencies in individual work and project outcomes
• Perform other duties as assigned by management

 FLSA Status: Exempt/salaried

 Compensation:  Salary available upon request. Includes full benefits package.