Employer: Advanced Clinical
Overview
This is a work from home position that can be worked remotely from anywhere in the United States
The Lead Data Manager is responsible for the data management project oversight resulting in quality and accuracy of the database for a clinical study. The Lead is the primary data management contact for the project and may also coordinate the work across multiple projects for a client program.
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.
Responsibilities
- Serve as primary point of contact for data management projects
- Coordinate and ensure the accuracy and completeness of activities for data management assigned study team members
- Present at study kick-off meetings, investigator meetings, client meetings, etc.
- Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications
- Perform user acceptance testing for assigned projects
- Create and maintain project timelines
- Prepare data transfer agreements & coordinate the receipt of data transfers
- Author all database lock documentation for assigned projects
- Prepare all data cleaning and data status documentation; including, but not limited to: metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
Standard Operating Procedures (SOPs)
- Strong understanding of departmental and company procedures; ability to guide others on procedures
Qualifications
- Minimum of 2 years direct data management experience in pharmaceutical development or CRO environment
- Bachelor’s Degree preferred. Work experience may be substituted for degree
- Working knowledge of CDASH standards
- Excellent oral and written communication skills, organizational skills, and attention to detail are required
Role Competencies
- Development of more advanced skills and knowledge relevant to the function. Able to perform routine assignments with little supervision and participate in more complex assignments.
- Maintains continuous, open and consistent communication with customers. Listen and ask questions to understand customer’s viewpoints.
- Establishes effective relationships with customers to understand and meet their needs. Ensures customer service standards are met.
- Questions currently accepted ways of doing things. Generates alternatives before settling on a solution.
- Manages own time and workload effectively. Supports team through achieving project deliverables and objectives.
