Principal 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:

• Acts as the Data Management program leader by ensuring consistency between studies for a sponsor, monitoring study timelines, evaluating, and mitigating project risks and reporting/reconciling project budgets.

• May act as the Lead Data Manager for one or multiple studies.

• Completes Data Management tasks for assigned studies under supervision according to the study contract and applicable SOPs.

• Develops and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Postproduction Database Change Control Documentation, Database Audit and Lock Procedures.

• Works with database programmers to design (e)CRFs and edit checks in EDC system.

• Creates test data for User Acceptance Testing (UAT).

• Performs and document database UAT.

• Receives, integrates, and reconciles electronic data.

• Performs data review via listings and EDC system, issue and resolve queries.

• Manages queries to ensure data completeness and integrity.

• Assists with data listing design for data review.

• Performs SAE reconciliation.

• Performs pre-lock and data lock tasks.

• Participates in client and team meetings as required.

• Designs, generates, and reviews status metric reports as needed.

• Performs archiving of study databases and related documents.

• Provides input to timelines to ensure timely completion of assigned tasks.

• Provides regular status updates and keeps the team and management informed of any changes.

• Organizes and file study documentation.

• Works with management and senior DM personnel to implement technical solutions and resolve issues.

• Trains and mentors data management staff, acts as a subject matter expert.

• Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences.

• Maintains knowledge of regulatory guidelines and industry standards applicable to clinical studies with specific emphasis on data management activities.

• Provides input to ProPharma Group SOPs as relevant to all data management activities.

• Other duties as assigned.

Requirements:

• Minimum BS in a scientific or health related field or the equivalent in years of experience.

• Minimum 10 years in Clinical Data Management.

• Minimum 5 years 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.*