Sr. Clinical Data Manager

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Essential Functions

• Act as the Lead Data Manager for one or multiple studies.
• Complete Data Management tasks for assigned studies under minimal supervision according to the study contract and applicable SOPs.
• Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
• Work with database programmers to design (e)CRFs and edit checks in EDC system.
• Create test data for User Acceptance Testing (UAT).
• Perform and document database UAT.
• Receive, integrate, and reconcile electronic data.
• Perform data review via listings and EDC system, issue and resolve queries.  Manage queries to ensure data completeness and integrity.
• Assist with data listing design for data review.
• Perform SAE reconciliation.
• Perform pre-lock and data lock tasks
• Participate in client and team meetings as required.
• Design, generate, and review status metric reports as needed.
• Perform archiving of study databases and related documents
• Provide input to timelines to ensure timely completion of assigned tasks.
• Provide regular status updates and keep the team and management informed of any changes.
• Organize and file study documentation.
• Work with management and senior DM personnel to implement technical solutions and resolve issues.
  
  

Requirements

• Minimum BS in a scientific or health related field or the equivalent in years of experience.
• Minimum 5 years in Clinical Data Management.
• Minimum 1 year acting as a Lead Data Manager on one or multiple projects (study start up through database lock).
  
  

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***